Sr Director of Process Sciences Apply to This Job

Company: ExecuNet
Location: Gaithersburg
Posted on: February 25, 2021

Job Description:

Company: Pharmaceuticals, Gaithersburg, MD Remarks: We are currently building worldwide manufacturing capacity for our COVID-19 vaccine, to allow for rapid scaling of production capacity in our goal of delivering 1-2 billion doses of vaccine in 2021. In parallel with that work, we are moving our NanoFlu vaccine program forward towards PPQ and licensure as well as preparing for future internal pandemic response vaccine capability. To assist with these programs, we are seeking a Director of the Process Sciences group within the Process Development Department, to coordinate technical oversight of manufacturing and process validation. Responsibilities include technical support of internal and external manufacturing, PPQ execution, process trending and analysis, and oversight of process change/comparability. The ideal candidate will be a highly motivated and flexible individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

Responsibilities include but are not limited to:

• Technical leadership to generate, review, and approve laboratory data to support investigations and troubleshooting of drug substance (DS) processes being operated at internal and external manufacturing.
• Accountability for continued process verification, including process monitoring programs across multiple manufacturing programs and manufacturing sites.
• Accountable for technical oversight of supplier-initiated changes and DS process changes.
• Contribute to the writing and reviewing of documents for INDs and regulatory section submissions.
• Collaborate with other CMC team members to build and execute the CMC development plan.
• Lead and develop a team of laboratory personnel.
• Provide leadership and direct support for tech transfer to manufacturing teams, including the preparation of draft batch records.
• Plan and execute confirmation runs (or manage and oversee execution of confirmation runs at external sites).
• Prepare or oversee the preparation of tech transfer reports and participate in the approval to move towards GMP manufacturing.
• In conjunction with site management, make key process related decisions when necessary.
• Establish appropriate process performance monitoring systems and assist in evaluating process performance.
• Interface with local and US based tech transfer teams to incorporate lessons learned which may apply to the NVAX manufacturing platform
• Train operations personnel in cell culture and purification unit operations and troubleshooting.
• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).
• Lead and/or support rapid troubleshooting of operational issues identified during site startup and GMP readiness.
• Provide guidance to operations team on best practices for manufacturing.--
• Master's degree in engineering or life sciences.
• 10 or more years of relevant experience in cGMP biologics manufacturing.
• Ability to succeed in a team-oriented environment under very dynamic conditions.
• Ability to collaborate with key stakeholders across a wide set of business disciplines
• Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing and good organization skills are required.
• Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.
• Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
• Demonstrated verbal and written skills in communicating scientific and technical information.
• Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.
• Proficient in Window based software including Excel, PowerPoint and Word. Highly Preferred/Desired Skills & Knowledge:
  • Experience with Sf9/BV expression system and manufacturing process.
  • Large scale commercial experience in technical or operational role.
  • Project management experience leading technical and/or complex projects.--
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Keywords: ExecuNet, Washington DC , Sr Director of Process Sciences Apply to This Job, Executive , Gaithersburg, DC