JOB SEEKER
Process Development Manager, Purification
Berkeley, CaliforniaDate Posted: October 29, 2011
Type: Direct Hire
Category: Pharmaceu
Job ID: 5546
Client: Major Pharma Mfg.
Title: Process Development Manager, Purification
Location: Berkeley, CA
Compensation:Salary $140K, Comprehensive Relocation Package
Fee is 25%
Candidates Must Have:
- Ph.D. in Biochemistry, Chemical Engineering, Biophysics, Pharmaceutics or related field
- Experience with protein purification of blood or recombinant proteins
- Experience in biotech commercial manufacturing
- Experience as people manager leading technical professionals
Our client, a global leader in the pharmaceutical industry has an opportunity for a Process Development Manager to lead a team of scientists and engineers dedicated to direct technical support and trouble shooting of commercial protein purification processes, implementation of process improvements, and process transfer for new technologies and processes.
Responsibilities include:
As a team leader, direct protein purification group to act as a liaison between process development and manufacturing by communicating requirements and directly participate in the development of standards/specifications for the justification, acquisition, and implementation of new manufacturing technologies, processes, equipment/facility replacements and upgrades, etc..
Manage and coordinate initiatives to identify, select, and introduce new pharmaceutical process improvements/technologies in the Berkeley manufacturing facilities.
Develop and implement strategies relating to new purification process improvements and capital investments which improve protein purification manufacturing process robustness in support of overall business goals.
Coordinate team initiatives to execute projects which improve commercial protein purification process robustness and production reliability at the Berkeley facility.
Evaluate and propose changes in purification specific processes/technologies to improve overall efficiency and/or regulatory compliance.
Directing small scale purification studies (AKTA Explorer and similar scale) for root cause investigation and feasibility assessments of process improvements,
Direct investigative studies using both protein column chromatography (ion-exchange, affinity, IMAC, etc) and filtration methods (TFF, UF, DF).
Other dimensions of the position include:
Participate directly in protein purification related process improvement and process transfer efforts relating to Berkeley biological and biotechnological pharmaceutical manufacturing.
Coordinate activities within company and other outside resources for the transfer of pharmaceutical technologies involving the Berkeley facilities.
Qualifications:
- Ph.D. in Biochemistry, Chemical Engineering, Biophysics, Pharmaceutics or related field, and 3+ years of Biotechnology industry experience
- Experience with protein purification of blood or recombinant proteins from animal cell culture or plasma.
- Experience leading technical professionals
- Effective written, oral and presentation communication skills.
- Experience with cGMP requirements in human therapeutic protein production.
- Significant hands-on protein purification experiences including affinity chromatography, ion exchange-IEX, and HPLC,
- Experience with the interpretation of standard protein analytical techniques such as oligosaccharide mapping, western blot, RF-HPLC, size exclusion (SEC) and ELISA.
- Comfort working with timeline requirements
- Specialized knowledge is required for a wide variety of process methods, equipment,
- Occupational and process safety and regulatory requirements to purify protein therapeutic proteins from animal cell culture or plasma derived feed material.
- Proficient knowledge of the equipment, chemistry, process flows and chromatography technologies used in the purification of therapeutic proteins is necessary.
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