Associate Director, Analytical Sciences - San Diego, CA | Biospace
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Associate Director, Analytical Sciences

Pfenex Inc.

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Location:
San Diego, CA
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
2017-07
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

The Associate Director, Analytical Sciences Separations reports directly to the Sr. Director, Analytical Sciences and serves as a Pfenex commercialization process team functional lead. They are responsible for analytical and biochemical characterization activities for biotherapeutic, protein-product development, including, but not limited to: assay development, characterization strategies and release testing for drug substance and drug product, process influence on product, and process/analytical investigations. This position must effectively communicate timelines and issues to ensure successful manufacturing, product testing/release and data package for regulatory filings.

Requirements

Technical Scope

•   Serves as Analytical Biochemistry (AB) SME in the development and commercialization of recombinant proteins that requires knowledge and application of analytical technologies involving separations (HPLC and CE), mass spectrometry, structural protein characterization, and compendium tests
•   Acts as a single-point-of contact on the Product Development Team (PDT), represents the Manufacturing department and associated sub-teams on AB analytical development work effort
•   Develops, implements, and manages state-of-the-art and fit-for-purpose analytical methods for product lot release testing, stability testing, product characterization, characterization of product degradation pathways, reference standard characterization and biosimilarity assessment
•   Keeps current in analytical development field including literature and technology development and regulatory driven activities
•   Authors detailed analytical reports and provides direct input/data/statistical analysis to support data package for regulatory submission(s) as well as BIAM, BPD, BLA, ANDA, and/or IND regulatory review meetings

Leadership Scope

•   Within the context of a product commercialization process, formally leads a cross-functional technical team on the delivery of analytical methods for product lot release testing, stability testing, product characterization, including timelines, milestones, methodological approaches, expected results, and necessary resources
•   Assembles and delivers CMC supporting regulatory documentation required to rationalize process analytical, characterization, and release specifications
•   Represents the Manufacturing Department in various departmental and interdepartmental committees that address functional, scientific, and/or industry initiatives
•   Collaborates effectively to achieve results as an individual as well as through others
•   Actively creates, generates, and presents papers/presentations at scientific meetings
•   Generates and delivers concise/clear technical presentations to senior management with minimal supervision
•   Promotes a culture of continuous improvement within Analytical Biochemistry; Acts as a champion on initiatives and/or projects to drive improvements in data quality and team performance
•   Generates and manages comprehensive budget and timelines for program project activities
•   Ensures laboratory and safety guidelines and best practices are followed and achieved in accordance with Company, State and Federal laws
•   Ensures PDT, individual, team, and corporate goals are achieved
•   Other duties as assigned or required

JOB SKILLS, ABILITIES AND QUALIFICATIONS

•   Bachelor of Science degree in Biology/Analytical Chemistry/Biochemistry/Biochemical Engineering or related field
o   Bachelor of Science degree 10 years of relevant experience w/a minimum of 5 years of industry experience
o   or Master of Science degree 8 years of relevant experience w/a minimum of 3 years of industry experience
o   or PhD 4 years of relevant industry experience
•   Expertise with one or more of the following techniques for analyzing proteins and peptides: HPLC, capillary electrophoresis, mass spectrometry, binding kinetics, circular dichroism, intrinsic fluorescence, light scattering, and immunochemistry techniques
•   Experience to include data analysis, statistical analysis, method transfers and comparability studies
•   Knowledge of upstream and downstream process development for biotherapeutic protein production
•   Scientific understanding of current analytical technologies, as well as the ability to explore and develop novel approaches to further advance innovative analytical methodologies
•   Proven working knowledge of GLP & cGMP compliance and ISO9000
•   Fluent in practical application of PC's, Microsoft Project, Word, Excel, PowerPoint as well as statistical experimental design/control software (e.g., JMP)
•   Must be able to travel up to 10% (US and internationally)
•   Demonstrated ability and experience as follows:
•   Ability to work flexible work schedules, including weekends, as required
•   Detail oriented and highly organized with a strong business/technical acumen
•   Digests complex information easily and communicates data back in a logical, effective and actionable manner
•   Easily builds relationships and works collaboratively with cross functional team members; external vendors; and customers alike
•   Effectively  meets deadlines and commitments
•   Excellent project- and time-management abilities and strong follow-through skills required
•   Manages and motivates others to achieve goals (even if not direct reports)
•   Proactively takes initiative to identify, research and solve complex technical problems and issues; communicates status in a timely manner
•   Works in fast-paced, team-oriented and self-directed entrepreneurial environment