Senior Director of Formulation, Drug Product and Analytical Development

Location
Austin, TX, USA
Posted
May 31, 2021
Ref
258665
Hotbed
Lone Star Bio
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics. Our proprietary biologic drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases. MTEM currently has multiple clinical-stage ETB candidates in development including MT-5111, TAK-169, and MT-6402. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking an experienced and dynamic professional to lead our Product Attributes Sciences (PAS) group aka Formulation, Drug Product and Analytical Development. PAS comprise the Attribute Sciences (AS) team developing and using separation sciences methods, performing biophysical and biological characterization, and Product Attributes Team Leaders (Principal Scientists) who manage the cross-functional CMC development activities.

This leadership role requires knowledge and experience in biochemical, biophysical and biological characterization of protein therapeutics to elucidate structure, assess modifications, determine size and charge variants, and define critical quality attributes (CQAs). Working cross-functionally with R&D, Translational Sciences and Clinical Development to understand structure-function relationship between product quality attributes and biological performance i.e. PK, PD, safety and efficacy is a major aspect of this role. The Senior Director will be responsible for coordinating, tracking and curating characterization data to understand trends and time-course profiles. Also, impact of processing, handling, storage and transportation conditions on drug substance and drug product quality attributes across the supply chain from initiation of drug substance manufacture to finished goods administration in patients.

This role will work closely with internal groups in Biopharmaceutical Development, Quality, Manufacturing, Supply Chain and Regulatory Affairs in setting phase-appropriate DS and DP specifications, define comparability protocols and execute comparability studies. This leadership role will extend to outside groups, such as contract development organizations and contract testing laboratories by overseeing services pertaining to production of drug substance and drug product, and analytical characterization studies. The Senior Director will work closely with upstream, downstream, formulation and drug product development teams, Quality and Manufacturing in defining control strategy across manufacturing unit operations, DS and DP release to attain CQAs at target specifications with batch-to-batch consistency.

This role will support product quality risk assessments and preparation of CMC regulatory submissions. This position will require excellent technical knowledge in biopharmaceutical drug substance and drug product development, analytical development, demonstration of sound decision making and problem-solving skills, along with ability to operate independently, collaborate with cross-functional teams, contractors, and external regulatory agencies.

Job Responsibilities will include:
  • Lead the Formulation, Drug Product and Analytical Development team to deliver high resolution separation sciences methods, execute biophysical and biological characterization using reliable and reproducible techniques and methods
  • Guide the Principal Scientists (Team Leaders) to manage the cross-functional CMC activities needed to advance ETB development and meet Regulatory CMC requirements
  • Interface with R&D, Translational Sciences and Clinical Development to build understanding of structure-functional relationship of ETBs for establishing and confirming CQAs
  • Interact with upstream, downstream, quality, DS manufacturing and DP CMO in the production, release, stability of drug substance and drug product to monitor and trend data for intermediates and final materials
  • Guide upstream, downstream, analytical and drug product development activities in establishing control strategy
  • Work with functions within CMC Development, Quality, Regulatory Affairs and Manufacturing in defining specifications from trending and analyzing batch and stability data
  • Develop comparability protocols and execute comparability studies
  • Interact with R&D, Process Technology and teams within Biopharmaceutical Development in the execution of Manufacturability Assessment
  • Support Product Quality Risk Assessments (PQRAs) and studies to fill data gaps with potential impact on product safety and biological performance
  • Support internal and external CMC activities required for regulatory filings
  • Prepare reports as needed for CMC modules for development and registration applications, annual reports, amendments, and supplements for submission
  • Support CMC regulatory responses and commitments according to agreed timeline
  • Maintain internal and external product characterization data and reports
  • Serve as Product Attributes Sciences expert and primary contact with external and internal clients

Qualifications:
  • Advanced degree in the Life Sciences or related field, required
  • Minimum of ten (10) years of relevant experience in pharmaceutical, biopharmaceutical drug development
  • Experience with biological therapeutics process development, manufacturing, analytical, formulation and drug product development
  • Experience in working with R&D, toxicology and clinical groups to understand protein therapeutics' product attributes impact on biological performance
  • Demonstrated experience with large molecule biologics and minimum two (5) years directly involved with CMC operations
  • Knowledge of upstream, downstream bioprocessing unit operations and analytical development in establishing control strategy
  • Knowledge of establishing CQAs and use of batch release and stability data to justify DS and DP specifications
  • Experience with extended biologic product characterization and comparability studies
  • Knowledge of manufacturability assessment and lead candidate selection
  • Excellent written and verbal communication skills
  • Excellent computer skills
  • Excellent analytical skills and problem-solving skills
  • Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
  • Ability to work collaboratively with cross-functional teams and contractors to drive results and meet company objectives
  • Ability to function independently and exercise good judgement, as well as in a team-based environment
  • Minimal travel required


Reporting Structure:

This position has supervisory responsibilities and reports to Vice President, Biopharmaceutical Development.

Molecular Templates celebrates and supports our differences and is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic. 

MTEM is committed to providing reasonable accommodations for qualified individuals. If you need assistance with your application due to a disability, you may contact us at: careers@mtem.com.

By submitting a resume for consideration, applicants verify that they have read MTEM's Applicant Privacy notice. https://www.mtem.com/privacy-policy

Molecular Templates Inc https://mtem.isolvedhire.com