1+ months

Technical Transfer Project Manager â?? Vaccine Development â?? COVID

Kelly Services
Remote, MD
Kelly is seeking a Project Manager in the Technical Operations Large Molecule team for work on the tech transfer of a vaccine from development to a commercial manufacturing site. This is a long-term role based in **Gaithersburg, MD** . Details for the position are as follows:


+ Scientist needed in the Technical Operations Large Molecule Global Team for a position of Drug Product Technical Owner/Technical Launch Integrator (New Product Introduction). This individual will be part of New Product Introductions.

+ The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place.

**Key Responsibilities:**

The TLI is a key function in New Product Introduction and is responsible for:

+ Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain (large and small molecule).

+ Single point of contact for plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support.

+ Technical input and technical acceptance of Drug Product into the supply chain including cost and robustness metrics through a process of touch points, thereby ensuring one voice of the customer towards R&D and consistency across projects and across plants.

+ Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of technical expertise (e.g., platforms, engineering, SMEs) into project execution and QbD technical implementation at the manufacturing site level.


+ Seven years of meaningful experience and BS degree or equivalent; Or 4+ years with advanced degree MS/MBA/PhD or equivalent.

**Experience and Skills Required:**

+ Strong project management skills with experience in supporting the execution of large-scale projects. You should have a sound sense of urgency, process-oriented skills, attention to detail, outstanding teaming and collaboration skills

+ Good communication skills including technical writing proficiency

+ A minimum of 7 years of experience and a BS degree, or advanced degree MS/MBA/PhD at least one area within these functions: Small Molecule and/or Large Molecule pharmaceuticals; research and development; Technical Operations; API/ Drug Product Manufacturing; Quality; Regulatory; Drug Development.

+ Ability to lead, encourage and coach project teams and individuals

+ The job requirements are specific and fast paced candidates should have a technical & manufacturing background with a detailed aseptic processing understanding, good project management and interpersonal skills

+ She or he should also be able work with Health Authorities and technical representatives from Partners and Contract Manufacturers, and to provide answers to HA questions on regulatory documents, ensure technical PAI inspection readiness, etc.

+ Knowledge in process validation, equipment qualification and aseptic process equipment requirements

+ Lead multi-functional and third-party teams for complex investigations, Tech Transfer and process improvement projects.

+ General knowledge of the pharmaceutical industry

+ Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with working technical knowledge of GMP.

+ Knowledge of manufacturing site systems and procedures


+ Proven ability to partner and work with multiple departments and manage projects. Experience with technical transfers involving cross-functional, cross-geography, and cross-company teams

+ Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams.

+ Foster team efficiency and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.

+ Influence peers, superiors, and partners.

+ Knowledge of both pharmaceutical product R&D and Technical Operations functions and experience with both small and large molecules.

+ Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations.

**This position comes with enhanced benefits which include:**

50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)

Paid sick days and vacation days

*benefits to be received upon meeting eligibility requirements

**_Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume._**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-07-13 Expires: 2020-09-14

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Technical Transfer Project Manager â?? Vaccine Development â?? COVID

Kelly Services
Remote, MD

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