Senior Director, Process Development
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Director, Process Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Is responsible for process and analytical development of the company’s platform products supporting pre-clinical, clinical studies and eventual transition to commercial supply.
- Provides leadership of the upstream and downstream manufacturing processes to produce mRNAs and LNPs.
- Provides science-based approach to process steps development and optimization to improve consistency and robustness.
- Authors and/or reviews regulatory submissions and provides technical input to regulatory discussions.
- Serves as a mentor and coach to CMC personnel, modeling behaviors and leadership aligned with company values.
- Manages the PDAS team.
- Provides guidance and direction for development strategy, goals, and budgets for PDAS.
- Oversees hiring to build an effective PDAS team. Creates and communicates a clear vision among direct reports, effectively aligns resources, and motivates teams to achieve corporate goals.
- An Advanced degree (MS, PhD, or MBA) in life sciences, engineering, or related field is required.
- Requires a minimum of 15 years of leadership experience in process and analytical development in the biopharmaceutical/pharmaceutical industry.
- Experience with plasmid, mRNA and LNP manufacturing related processes and scale-up is required.
- Must have a strong grasp and application of fundamentals pertaining to process development, tech transfer, and process validation activities.
- The ability to work in cross-functional teams effectively and interacting with external collaborators to build strong relationships is required.
- Must have experience in managing and working with CDMO/CMOs.
- Must be available to travel when needed.
- Must have strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization.
- Requires an entrepreneurial approach to develop new, innovative ideas that will drive growth within the PDAS organization.
- Must have the ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion.
- Requires strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
- Must have excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues to the executive leadership.
- Must be able to develop effective and efficient working relationships with both internal and external partners.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
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