|
Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good job fit arises.
Back to Jobs home
1) Distribution Project Manager – 4 month contract (New Jersey) 820
2) Senior Director, Commercial Drug Manufacturing – Full Time Position (San Francisco Bay Area) S54NG
3) Director/Sr. Director Supply Chain Management- Full Time Position (San Francisco Bay Area) BB30Q
4) Manager/Sr. Manager Clinical Supply Chain – Full Time Position (San Francisco Bay Area) T12AS
1) Distribution Project Manager – 4 month contract (New Jersey) 820
DESCRIPTION:
This position manages the distribution logistics for assigned projects. Applies the distribution plan and schedule in the most efficient and competitive way within the agreed timelines and meeting the internal or external customer requirements. Coordinate efforts within the global distribution organization. This activity supports the efforts of the larger, global Clinical Supplies Scientific Core Platform and R&D. This role will lead or assist in the implementation of improvements in distribution strategy, quality, regulatory compliance, cost effectiveness and efficiency.
Duties:
- Contribute to the development and apply the distribution strategy (for IVR and non-IVR studies) that ensures continuity of IP at depots and investigational sites.
- Ensure adequate IP stock at depot and site levels.
- As necessary, support relabeling activity or transfer of IP between various sites.
- Ensure all critical parameters are considered for every distribution strategy; IVRS/IWRS specifications (e.g. initial or resupply quantities); any QP, project, study, expiry, customs, import/export, brokerage or country specific requirements.
- Generate and/or review IP shipment requests for accuracy & completeness prior to issuance.
- Ensure accuracy of IP receipt for all shipments and availability in IVR for applicable studies.
- Serve as point of contact for all contracted distribution activities.
- Provide adequate communication and documentation (including customs values) relevant to the distribution plan and the movement of all investigational products.
- Contribute to the quotation for customers; distribution projects to include budgeting and forecasting.
- Generate and maintain data for distribution metrics.
- Offer creative solutions/proposals to optimize the distribution supply chain.
EXPERIENCE AND QUALIFICATIONS:
- Excellent knowledge of business units, scientific core platforms and interfaces, clinical study protocols and IP related activities with particular emphasis on global distribution and strategy
- Thorough understanding of GMP & GDP (IP production and distribution)
- Thorough understanding of IVR/IWR systems
- Good understanding of CMC and clinical study conduct activities
- Excellent ability to interface with customers and distribution partners (couriers, brokers, vendors)
- Excellent oral and written communication skills
- High attention to detail
- Excellent negotiation skills
- Strong problem solving skills
- Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization; effective time management skills
- Exercises calm, sound constructive judgment during high demanding situations
- Ability to organize and lead meetings.
- Experience with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software required.
- Bachelor of Science degree (BS) in Health Science or related discipline and at least 3 to 5 years experience in pharmaceutical business experience required.
- Must be well versed in all aspects of the clinical supply chain process, GMP, GDP and other regulatory requirements as they pertain to investigational products.
To apply for a position send your resume to Jobs@JGBBioPharma.com
2) 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
3) Director/Sr. Director Supply Chain Management- Full Time Position (San Francisco Bay Area) BB30Q
DESCRIPTION:
- This position will focus on managing CMOs to provide the global commercial supply of drug product and drug substance. This includes a focus on labeling and distribution
- Oversee and manage all logistics activities and related systems information in a clinical and commercial manufacturing environment. Areas of responsibilities include but not limited to supply chain management, inventory control or critical parts inventory, material handling, import-export licensing, shipment of products from place of origin to point of delivery, and third-party warehousing.
- Develops and implements logistics plans, budgets, and procedures to maximize compliance with the Company’s business objectives. Provide financial reporting and reconciliation of inventories. The ideal candidate will exhibit a thorough understanding of international Letters of Credit and other forms of banking documents as well as international shipments.
- A director level position may participate in the development of corporate and/or organizational policies which may include the authorization to implement such policies. This position level provides general direction to and review of manager level personnel in various functional areas and/or teams.
- Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Works on abstract problems across functional areas of the business; identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Erroneous decisions may have a serious impact on the overall success at the functional and/or program level.
MAJOR DUTIES OF POSITION:
- Create and execute long-term supply chain strategies that align with corporate objectives.
- Develop and execute sourcing strategy for materials based on current business needs. Drive materials productivity through negotiations, improving supplier efficiency, and collaboration with appropriate functions to design cost resourcing.
- Works closely with the appropriate management team to develop long term capacity plan.
- Maintain current and accurate supplier performance statistics and provide timely reports.
- Develop tactical methods to overcome real-time material issues.
- Work closely with cost accounting, manufacturing, distribution, clinical, commercial development and other related departments to develop annual, quarterly, and monthly supply chain plans.
- Partner with key stakeholders to develop, implement, and influence best practices in the disciplines of forecasting supply chain management, inventory management, and master scheduling aligned with the commercial strategies and programs in the clinic.
- Reduce material variances by efficient use of materials, root cause analysis of scrap material and adherence to material management process.
- Responsible for supporting new product development with all material requirements and make recommendations for supplier optimization.
- Represent the Global Technical Operations group on project teams and when appropriate, at senior management meetings.
- This position may travel up to 25%.
EXPERIENCE AND QUALIFICATIONS:
- BS in Operations Management, Purchasing/Procurement, or Supply Chain Management with 10+ years’ relevant pharmaceutical industry experience and at least 5 years experience in a strategic leadership and management role, preferably at the director level. An MBA is a plus.
- Substantial experience setting up Global Distribution Centers
- Demonstrated knowledge of material management principles and concepts for clinical supplies and commercial manufacturing.
- Proven ability to develop and implement strategic business plans; global sourcing and logistics experience is required.
- Knowledge of federal, state, and local regulations and The Joint Commission requirements.
- Demonstrated competencies in operation of inventory control systems and software applications.
- APICS, MAPICS, CPIM certification strongly desired.
- Proven ability to translate business objectives to effective technical and operational plans and successful implementation of such plans.
- Demonstrated ability in synthesizing information to make critical decisions in a timely manner as well as develop short and long-term plans.
- Excellent communication and interpersonal skills with proven ability to build positive work relationships across functional lines and to motivate employees.
- Ability to quickly ascertain pricing, quantity and lead time impacts on purchased products relative to business conditions of the industry and overall supply chain strategy.
- Excellent negotiation skills with proven performance in a sourcing environment.
- Strong financial, business, matrix management, and influencing skills.
- Demonstrated ability to effectively manage multiple products and projects.
- Proven leadership ability and problem-solving skills are a must.
- Personal attributes required include:
- Flexibility and integrity,
- Goal oriented and self-starter,
- Practical approach to problem solving,
- Demonstrated good judgment and decision-making experience,
- Collaborative and team oriented.
To apply for a position send your resume to Jobs@JGBBioPharma.com
4) Manager/Sr. Manager Clinical Supply Chain – Full Time Position (San Francisco Bay Area) T12AS
DESCRIPTION:
The Manager of Clinical Supply Chain ensures that all clinical trials have timely and adequate supply for administration to subjects. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. The manager role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, and return or destruction. Additionally the manager implements and ensures group compliance to procedures for the production and distribution of investigation product.
Responsibilities include:
- Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time Managing clinical labeling including label design and manufacturing.
- Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts.
- Importing and exporting clinical trial material.
- Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors.
- Setting up Integrated Voice and Web Response Systems with the clinical team.
- Interfacing between the CMC and clinical teams.
EXPERIENCE AND QUALIFICATIONS:
- BS/BA degree.
- Minimum 3-5+ years industry experience in clinical operations or supply chain management. Title based on experience.
- Experience with clinical blinding practices.
- Experience setting up Integrated Voice and Web Response Systems.
- Working knowledge of drug development process (Phase I-IV).
- Working knowledge of cGMPs.
- Experience with clinical labeling, packaging and distribution including cold chain, importing and exporting.
- Strong analytical and problem solving skills.
- Ability to handle multiple projects simultaneously.
- Proven project management skills.
- Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.
- Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Microsoft Project.
To apply for a position send your resume to Jobs@JGBBioPharma.com
|
