Associate Director Process Development

Associate Director, Commercial Drug Products & Life Cycle Management What you will do

• Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of parenteral and/or oral solid dosage presentations.
• Lead a team of scientists focused on late‑stage drug product process development and tech transfer and coach staff with emphasis on people‑centered leadership.
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non‑conformance investigations and process changes/improvements.
• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
• Participate and lead global cross‑functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and develop responses to regulatory questions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
• Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
• Ability to travel domestically and internationally up to 10% of the time.

• Doctorate degree and 3 years of experience in engineering or science
• Masters degree and 7 years of experience in engineering or science
• Bachelors degree and 9 years of experience in engineering or science
• Associate’s degree and 12 years of experience in engineering or science
• High school diploma / GED and 14 years of experience in engineering or science

In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

• PhD from an accredited college or university in one of the following areas:
  Biotechnology, Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering, Biomedical Engineering or a related scientific subject area
• 8+ years of pharmaceutical development and management experience
• 8+ years of relevant formulation and process development experience within a major biopharmaceutical or pharmaceutical organization
• Demonstrated knowledge of drug product commercialization and integrated combination product development with hands‑on experience with end‑to‑end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
• Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
• Understanding of physical/chemical stability of proteins and how process‑related stress impacts product quality, specifically the impact of freezing and drying on short- and long‑term stability
• Strong knowledge about developing processes with single‑use manufacturing equipment
• Aseptic processing experience and familiarity with cGMPs, ICH guidelines
• Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong problem solving and effective cross‑functional communication skills
• Proven ability to learn and act on dynamic information at a rapid pace
• Ability to participate in global cross‑functional teams and work effectively in a highly matrixed environment to lead change, efficiency, and…