Associate Director, Process Development

The Associate Director, Process Development supervises a team of 10-15 scientific staff who perform optimization, characterization, and troubleshooting of formulation, filling, and finishing processes for protein parenteral products. Further, the Associate Director applies his/her exceptional skills of scientific principles to the design and implementation of protein freeze-thaw, ultrafiltration / diafitration, formulation, sterile filtration, mixing, filling, and/or lyophilization operations; independently reviews the appropriateness of data, design and execution of group experiments; and effectively communicates with senior management and develops strategic plans for a technical group.
REQUIREMENTS
Basic Qualifications:
M.S. in Pharmaceutical Sciences, Biochemical Engineering, or Biotechnology.
13 or more years of experience within a pharmaceutical/biotechnology organization working with protein biochemistry, specifically chemical and physical stability, on technical transfers, comparability issues, and regulatory filings for fill finish or lyophilization processes of biotechnology therapeutics.

Preferred Qualifications:
Ph.D. with 10 or more years of above-mentioned experience.
Ability to work in a matrix team environment and interact effectively with representatives from Analytical Sciences, Pharmaceutics, Purification Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality.
Excellent written and verbal communication skills.
Leadership skills, including demonstrated ability to manage scientific staff.