Chemistry, Manufacturing, and Control (CMC) Jobs

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1) Associate Director, Analytical Chemistry – Full Time Position (San Diego, CA) GO60C

2) Vendor Manufacturing Project Manager – Full Time Position (San Francisco Bay area) S54YB

3) (Senior) Research Associate (RA) Formulation Development – Full Time Position (San Francisco Bay area; Relocation provided; Current US Work status only) G62SB

4) Sr Engineer Manufacturing Technical Specialist – Lyophilization (Full time position, Oregon) KC62S

5) Manager / Sr. Manager Oligonucleotide – Full Time Position (San Francisco Bay Area) G56CW

6) (Senior) Director Pharmaceutical Sciences – Full Time Position (San Francisco Bay Area) B56GR

7) Senior Director, Commercial Drug Manufacturing – Full Time Position (San Francisco Bay Area) S54NG

8) (Senior) CMC Technical Writer – Full Time Position (San Francisco Bay Area) B30QP

1) Associate Director, Analytical Chemistry – Full Time Position (San Diego, CA) GO60C

DESCRIPTION:

• The qualified candidate will be a highly motivated and seasoned professional with experience in bioanalytical testing to support the development of recombinant biopharmaceuticals. The candidate will oversee technology transfer and technical operations for specific GLP bioanalytical (PK, immunogenicity, and pharmacodynamic biomarker) assays that support pre-clinical and clinical testing of specific recombinant biological product candidates.
• Responsible for technical operations to support specific assays and critical reagents at CRO’s used to quantify in vivo levels of protein drugs and anti-drug antibodies in accordance with current guidelines and industry standards. The individual will also be responsible for compiling datasets to support regulatory filings for specific programs.
• Must be organized and efficient and able to work on multiple programs independently with minimal direction to meet corporate goals and objectives. A successful candidate will also have strong interpersonal skills to communicate results to colleagues in a timely manner as well as provide oversight for activities at Contract Research Organizations. Finally, the candidate will generate documentation to support regulatory filings.

Essential Functions and Responsibilities:

• Significant knowledge and experience working within the regulatory framework and considerations for bioanalytical testing of recombinant biotechnology-derived products.
• Significant knowledge and experience in the pharmacokinetic evaluation of parenteral therapeutics, drug metabolism, and protein/drug properties governing their in-vivo distribution.
• The applicant must possess the ability to work effectively in a fast paced start-up setting.
• Clear and effective written (report writing) and oral communication (presentation) skills are essential.
• Must have the ability to work independently as well as in a team environment.
• Technical support of pre-clinical pharmacology, clinical, and bioanalytical sciences groups as required.
• Other functions as determined by the pre-clinical group.

EXPERIENCE AND QUALIFICATIONS:

• Advanced degree (PHD, MD, MSc or M. Pharm) in Pharmacology or related discipline is preferred.
• Significant knowledge and experience working within the regulatory framework and considerations for bioanalytical testing of recombinant biotechnology-derived products.
• Bioanalytical background with at least 8-10 years experience hands on experience in a pre-clinical and clinical drug development environment.
• At least 3 years experience in evaluation of biological therapeutics, preferably in a clinical or non-clinical setting biologics environment.
• In depth knowledge of PK and PK/PD evaluation techniques preferred. Experience of working in a team environment a plus.
• Knowledge of regulatory requirements and experience in dealing with regulatory authorities either through written summaries or oral presentations is desired, but not essential.
• The individual must be very effective at technical and scientific problem solving in a project driven, multi-disciplinary international environment, able to focus and work on
• several projects simultaneously and must possess excellent interpersonal, leadership and
• teamwork skills with very good organizational skills.
• Must be fluent in written and spoken English
• Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: e.g., ELISA plate reader, MSD, TaqMan, HPLC, Luminex, etc.
• Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Prism GraphPad, Softmax, MSD, JMP, StatLIA, WinNonlin, etc
• It is imperative that this individual be first and foremost a team player. They will be responsible to ensure that adequate resources are available and provide regular updates to their supervisor and team members. This will require that the individual be transparent and openly communicate information in a timely manner.
• Travel may be required up to 30% of your time

To apply for a position send your resume to Jobs@JGBBioPharma.com

2) Vendor Manufacturing Project Manager – Full Time Position (San Francisco Bay area) S54YB

DESCRIPTION:

• Serve as the primary commercial liaison between the company and external business partners engaged in commercial start-up or ongoing commercial activities. Coordinate the development of comprehensive project plans, schedule and run meetings, coordinate follow up activities and create/distribute status reports.
• Reports to the VP of Manufacturing and is focused on planning, execution, documentation and management of commercial manufacturing activities between the company and suppliers of commercial products/services. The focus is on smooth and steady manufacturing operations with an emphasis on quality throughout all activities. These projects may involve a broad range of technical and commercial subject matters that typically support the introduction and/or ongoing manufacture of pharmaceutical products and medical hardware. The Vendor Project Manager oversees and manages operational aspects of ongoing commercial projects, serves as the liaison between the project team, line and senior management, and associated vendors, executes process validations, manages schedules, provides forecasts, assesses risks and prepares status reports. The Vendor Project Manager is responsible for providing directions, management and assistance to multiple cross-functional sub-teams, and will collaborate with external manufacturing resources as well as with internal departments.
• These activities will focus on management of day-to-day activities involving nonconforming material/process deviations, coordinate internal MRB activities with respect to vendor supplied material, execution of validation/revalidation plans and coordinating periodic vendor management reviews.
• Responsible for execution of capacity expansion plans as well as quality improvement initiatives. Also be responsible for commercial activities including management of Commercial Supply Agreements, preparation of production forecasts, onsite inventory management and COGS as it is applied to a vendor’s products and services.
• Develops and manages formal project plans, with identified critical paths, timing, cost, resource requirements/allocations and risk mitigations.
• Manages day to day production issues as they develop.
• Calls in technical, quality and regulatory subject matter experts as needed to address issues as they arise.
• Represents Vendor at internal MRB activities Ability to manage multiple concurrent production lots with a high yield and minimal delays.
• Demonstrated management skills with complex projects that have a significant effect on company’s business performance.
• Provides leadership for a diverse array of cross functional teams addressing quality, commercial and organizational issues.
• Responsible for supporting COGS management and achieving cost reduction goals.
• May support execution of validation activity and regulatory filings (initial and annual).
• Required to present technical, quality, and commercially focused information to diverse audiences in a clear and consistent manner. Prepares meeting minutes and action item lists.
• Coordinate with team on issues such as technical concerns, capacity expansion, alternative manufacturing processes and yield improvement initiatives.
• Assesses project issues and develops resolutions to meet productivity and quality goals.
• Manages and provides leadership and mentorship to cross functional team and direct reports.
• Up to 20% domestic / international travel

EXPERIENCE AND QUALIFICATIONS:

• BS/BA degree in a hard physical science or engineering and 5-10 years of related experience; or, MS/MA degree and 3-5 years of related experience. MBA is encouraged.
• Familiarity with MRP systems is strongly desired.
• People management skills – negotiation, influencing and building relationships. Effective interpersonal and communication skills.
• Understands and is comfortable operating with FDA Good Manufacturing Practices.
• Analytical / statistical problem solving (e.g. Six Sigma training) is a plus.
• Ability to read, analyze and interpret the complex documents, ability to respond effectively to sensitive inquiries or complaints. Applies technical standards, principles, theories, concepts and techniques.
• Organizes and prioritizes numerous tasks and completes them under time constraints.

To apply for a position send your resume to Jobs@JGBBioPharma.com

3) (Senior) Research Associate (RA) Formulation Development – Full Time Position (San Francisco Bay area; Relocation provided; Current US Work status only) G62SB

DESCRIPTION:

• The individual will be involved in late-stage pharmaceutical development of monoclonal antibodies, antibody-drug conjugates, and delivery systems for clinical evaluation and commercialization.
• The responsibilities of this role include formulation development, evaluating product stability and throughout the manufacturing process and performance in diverse delivery systems, as well as biophysical characterization, drafting technical documents and contributions to regulatory filings.
• Applicants should be comfortable working both independently with minimal supervision and as part of a team to support the development of recombinant protein therapeutics.
• The successful candidate will also be expected to participate on cross-functional project teams.
• The position offers opportunities for professional and scientific growth in a dynamic, intellectually stimulating and fast-paced work environment.

EXPERIENCE AND QUALIFICATIONS:

• B.S. or M.S. in biochemistry, chemistry, pharmaceutics, chemical engineering or a related field with 5 to 10 years for Senior RA (and 3 to 5 years for RA) of relevant laboratory (industrial) experience is required.
• Must have strong scientific/ analytical skills and experience characterizing proteins with multiple chemical and biophysical techniques (SEC, IEC, RPLC, etc.) electrophoretic methods (icIEF, SDS-CE), spectroscopy, and other protein formulation/ biophysical characterization techniques.
• Strong oral and written communication skills, as well as excellent documentation and organizational skills are essential.
• Highly self-motivated, and possess strong problem solving and interpersonal skills to facilitate cross-functional interactions and collaboration with others.
• Prior experience representing formulation development on cross functional teams is requisite for the senior RA role.
• GLP experience is desirable.

To apply for a position send your resume to Jobs@JGBBioPharma.com

4) Sr Engineer Manufacturing Technical Specialist – Lyophilization (Full time position, Oregon) KC62S

DESCRIPTION:

Reporting to the Manufacturing Manager, the Sr Engineer / Sr. Manufacturing Technical Specialist, is accountable for leading the successful transfer of new and existing drug products to the Oregon manufacturing facilities in a timely manner. Lead multifunctional teams for technology transfers, identify, advise senior management as well as implement new technologies. Drive process improvements, identify equipment/process gaps, collaborate with Process R&D, regulatory, quality and compliance.

• The Sr Engineer / Sr. Manufacturing Technical Specialist is responsible for demonstrating leadership in technology transfer, new facility start up, and support day-day manufacturing operations. Providing subject matter expertise in support of novel state of the art equipment and processes e.g. Time-Pressure Filler, Closed Stopper Processing, Lyophilization, Aseptic Manufacturing Principles, product impacts and critical quality attributes. Foster teamwork, align with company as well as department goals and priorities. Apprise management of complex issues, escalate issues in a timely manner and provide regular status updates on the progress of projects and requests for meeting reviews as needed.
• Provide leadership in:
• -Developing business processes and establishing documentation systems for successful execution of technology transfer, identifying and implementing new technologies
• -Lead, supervise, mentor and develop Manufacturing staff
• -Safety, assuring that all processes are designed and operated in the safest possible manner, consistent with all appropriate regulatory and corporate requirements
• -Adhering to the highest quality standards to produce safe products for patients
• -Continuous process improvement, trouble shooting through partnership with the Operational Excellence organization
• The following are additional duties / responsibilities / accountabilities of the position:
• -Review and approve GMP documentation during product transfers and regulatory submissions
• -Establish and maintain solid working relationships with other departments in the network. Strengthen partnerships with other groups to meet department and company goals
• -Maintain authority in the drug product manufacturing filed e.g. Aseptic manufacturing, lyophilization, PAT, both inside as well as outside as demonstrated through presentations and publications
• -Well networked within the industry and academia in the aseptic drug product manufacturing equipment, processes and products

EXPERIENCE AND QUALIFICATIONS:

• Lyophilization experience REQUIRED
• 10+ to 15 years of pharmaceutical experience
• Minimum Education – Bachelor’s Degree
• Willingness to Travel Occasionally

To apply for a position send your resume to Jobs@JGBBioPharma.com

5) Manager / Sr. Manager Oligonucleotide – Full Time Position (San Francisco Bay Area) G56CW

DESCRIPTION:

• Manage the Chemistry Manufacturing and Control (CMC) activities related to oligonucleotide development programs. Work with internal teams and contract manufacturing organizations (CMOs) to manage and execute strategies for Phase 1 through Phase 3 clinical development of lead molecules. Oversee and integrate process development, pharmaceutical development , quality/regulatory and logistical aspects of generating clinical supplies. Manage and author appropriate development reports for support of regulatory filings. Other areas of responsibilities include but not limited to oligonucleotide manufacturing and support of early development supply of oligonucleotides.
• This level manager receives assignments in the form of objectives and establishes goals to meet objectives. Incumbent manager provides guidance to subordinates to achieve goals in accordance with established policies. The work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which affect subordinate organizations.
• This position works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors and exercises judgment within generally define practices and policies in selecting methods and techniques for obtaining solutions/results. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

Major duties of position:

• Works closely with the appropriate project team(s) as the Global Technologies
• Operation’s representative for oligonucleotide development to ensure effective operational execution.
• Manage the CMC aspects of oligonucleotide development (process development, manufacturing, QC etc).
• Manage external manufacturer relations and deliverables to ensure timely and effective delivery based on project deliverables.
• Develop tactical methods to overcome real-time manufacturing issues.
• Responsible for supporting new oligonucleotide development through external vendors.
• This position may travel up to 10%.
• Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

KNOWLEDGE AND SKILL REQUIREMENTS:

• BS/MS in Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutics, or closely related discipline and 5+ years’ relevant industry experience.
• At least 2 years experience in a pharmaceutical CMC/GMP environment.
• Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC.
• Exceptional written and verbal communication skills.
• Proven ability to implement against strategic plans.
• Project management and team leadership experience is required.
• Demonstrated competencies in a core CMC discipline such as formulations, manufacturing, and/or chemical synthesis.
• Demonstrated ability in synthesizing information to make critical decisions in a timely manner.
• Exceptional interpersonal skills with proven ability to build positive work relationships across functional lines and must possess the ability to motivate employees.
• Must possess the ability to effectively manage multiple projects.
• Proven problem-solving skills are a must.

To apply for a position send your resume to Jobs@JGBBioPharma.com

6) (Senior) Director Pharmaceutical Sciences – Full Time Position (San Francisco Bay Area) B56GR

DESCRIPTION:

The incumbent in this position is expected to partner with other members of the Company’s scientific team to apply the company’s core technology in the identification and advancement of new product opportunities. Initiate, manage and lead pharmaceutical sciences technology activities that contribute to the development of the company’s scientific portfolio and product programs. Development of corporate and/or organizational policies.

MAJOR DUTIES OF POSITION:

• Provide leadership and direction to the Biological Product process development, scale-up and technical transfer, formulation development, and the evaluation of drug presentation formats
• Collaborate with manufacturing, analytical development, regulatory, and quality to achieve pharmaceutical science initiatives.
• Support early research programs in all areas of pharmaceutical sciences.
• Author CMC sections for regulatory submissions.
• Act as primary contact for related contract manufacturing activities.

EXPERIENCE AND QUALIFICATIONS:

• PhD in Chemical or Biochemical science with 10+ years relevant work experience including 5 years management experience, preferably at the director level, in a CMC discipline such as Process Development, Formulations, etc.
• Five years experience in preparing reports for Regulatory submissions.
• Familiarity with biologics drug development.
• Knowledge and experience in Quality by Design and DOE principles.
• Proven success in leading multidisciplinary project teams.
• Proven experience with upstream and downstream process development as well as formulation screening.
• Understand the Company’s business direction and make significant contributions to new technologies, applications or business opportunities.
• Demonstrated ability in translating strategic objectives – both at the business and scientific level – to tactical and/or operational deliverables.

To apply for a position send your resume to Jobs@JGBBioPharma.com

7) Senior Director, Commercial Drug Manufacturing – Full Time Position (San Francisco Bay Area) S54NG

DESCRIPTION:

Reports to VP Technical Operations. Responsible for a complex supply chain delivering drug and drug/device combinations. Provides vision concerning means and methods of achieving high-level corporate targets that have a very direct impact on the overall performance of the company. Includes, but is not limited to ensuring the quality and availability of products to meet forecasted company needs. Key management responsibilities include MRP/Production Planning, Commercial Manufacturing Operations, application of automation tools for high-volume manufacturing, Sustaining Engineering, Distribution Management/Logistics and Inventory involving the Company’s products in commercial distribution. Manufacturing and logistics resources may be provided by the Company, third parties, or combination processes. Creates an environment where FDA quality systems are effectively used to deliver products that consistently meet product specifications and delivery schedules. Key metrics include product yield, on time performance, audit findings and budget management. Budgetary responsibility is considerable and emphasis is placed on achieving specific Cost of Goods (COGS) targets. Responsible for operating all activities in manner that complies with appropriate safety, regulatory and legal requirements. Works in close collaboration with internal cross-functional teams, as well as third party suppliers to develop plans and measure performance against plans. Fosters a high performance environment and help grow junior members of the company by providing mentoring and other professional growth advice/assistance.

Essential Duties and Responsibilities:

• Responsible for development and execution of commercial manufacturing operational strategies using virtual and/or captive resources.
• Assures that quality and production goals are fully executed according to predefined goals.
• Provides leadership for a diverse array of cross functional teams addressing quality, technical, commercial and organizational issues.
• Recommends and build business cases to support capital equipment and staff expenditures.
• Works cooperatively with a wide variety of stakeholders including third party suppliers as well as Company’s resources.
• Responsible for ensuring that the Company’s policies, procedures, procedures are followed and all facilities comply with GMP and other regulatory requirements.
• Ensures budget performance meets corporate objectives.
• Responsible for managing COGS and driving cost reductions.
• Manages a diverse array of projects at multiple vendors to achieve specific strategic and operational goals.
• Coordinates transition of new products from development to commercial operations.
• Ensures information is effectively communicated and managed.
• Required to present technical and commercially focused information to diverse audiences in a clear and consistent manner.
• Provides troubleshooting services for a variety of technical, quality, regulatory and commercial issues.
• Performs other activities as defined by management and project team requirements.
• Supports junior members of the organization by providing mentoring services as appropriate.
• Ability to travel nationally and internationally (20% of the time).

EXPERIENCE AND QUALIFICATIONS:

• BS/BA degree in related discipline and 11 years of related experience; or,
• MS/MA degree in related discipline and 9 years of related experience; or,
• MBA is encouraged but not required.
• Advanced degree in engineering, technical or operations discipline required or related experience in a similar environment producing drug/device.
• Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.
• Thorough understanding of pharmaceutical manufacturing processes through final packaging.
• Requires experience with increasingly responsible technical management positions in a commercial drug/device manufacturing environment.
• In depth experience with FDA and industry and international regulatory and safety guidelines (21 CFR part 11, GMP, ISO, etc.).
• Experience with the development of new product developments, including NDA writing. Focus of NDA work shall be CMC and validation.
• Solid working knowledge of ERP system capabilities.
• Proven track record of success meeting pharmaceutical quality and production schedule goals in a high volume environment.
• Demonstrated ability to successfully operate and direct 3rd party vendors supplying products and services.
• Experience with high-speed automation systems for manufacturing processes.
• Thorough understanding of drug development, commercialization, manufacturing and packaging processes.
• Demonstrated ability to multi-task in high pressure, changing conditions in a global development and manufacturing environment.
• Excellent computer user skills working with MS Office suite and strong working knowledge of a major ERP system (SAP, Oracle or equivalent).

To apply for a position send your resume to Jobs@JGBBioPharma.com

8) (Senior) CMC Technical Writer – Full Time Position (San Francisco Bay Area) B30QP

DESCRIPTION:

In collaboration with manufacturing, process development, and/or QC, manage and lead the activities related to creating and editing CMC documents and reports, and other related written materials. This position is responsible for gathering CMC source documents and other scientific data and developing a range of documents in narrative and/or summary format to deliver concise and accurate technical and scientific data that is suitable for further regulatory utilization.

At this level, incumbent uses professional skills to contribute to the development of Company concepts and principles to achieve objectives in creative and effective ways.

Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

MAJOR DUTIES OF POSITION:

• Lead and initiate the creation of CMC documents and reports from source documents and other scientific information in collaboration with the Technical Operation’s team.
• Produce final documents in narrative and/or summary format that effectively deliver concise and accurate technical and scientific data appropriate for regulatory utilization.
• Develop and manage document creation timelines aligned with the overall project schedule to ensure CMC documents are submitted in accordance to project deadlines.
• Work with the CMC team on quality control of documents and meeting deadlines.
• Work closely with the CMC team to ensure understanding project requirements and to stay abreast of project changes.
• Establish appropriate communication flow with other departments, such as Regulatory Affairs, to update CMC sections of annual reports and other related reporting requirements.
• Coordinates within CMC to ensure deadlines from project teams are met and/or potential delays are communicated appropriately.
• Facilitate resolution of inter-departmental issues pertaining to project priorities and team dynamics.
• Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:

• Manager level – BS or MS in life science with 5+ years experience in CMC and/or process development and/or Quality Control focused in therapeutic pharmaceutical development. At least 2 years of management related experience.
• Must have directly authored CMC documents (e.g. not just reviewed / edited)
• Must understand the components and/or process of biologic drug development.
• Knowledge of FDA and EU regulatory requirements for biologics and pharmaceuticals is plus.
• Experience with regulatory agencies concerning inspections and questions related to submissions for product approvals highly desirable.
• Excellent written communication skills and proven ability to translate technical data into concise narrative/summary.
• Must possess the ability and desire for problem solving and decision making in a cross-functional team setting.
• High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
• Excellent interpersonal and verbal communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company.
• An effective leader who will work proactively to drive results.
• Proven ability to establish collaborative working relationships; team oriented and must be able to work independently.

To apply for a position send your resume to Jobs@JGBBioPharma.com