Director/ Senior Director, Formulation and Drug Product Development

Location
Austin, TX, USA
Posted
Sep 05, 2020
Ref
156779
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM currently has several ETB candidates in clinical development including MT-3724 and MT-5111. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.

Position Overview:

Molecular Templates is seeking an experienced and dynamic professional to strategic direction and technical leadership for creation, development and characterization of novel formulations and drug product (DP) manufacturing processed for new products to support their evaluation in preclinical and clinical studies. The successful candidate will have proven experience in leading scientific teams and managing CROs and CMOs. This leader will possess a deep understanding of formulation development for therapeutic proteins to lead the efforts on new and existing products.

Responsible for the design and management of studies, protocol development, data evaluation, preparation, review and completion of study reports to support drug product and formulation sections of investigational new drug applications (INDs) and Biological License Applications (BLAs). The successful candidate will work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. This position requires expert ability in designing and executing stability studies for DS and DP, compatibility studies for clinical application and analysis of the data outcome.

Job Responsibilities will include:
  • Provide strategic leadership, technical expertise, and specialized knowledge in formulation development to support testing of new drug products.
  • Provide strategic oversight for drug product manufacturing and dose presentation strategy development.
  • Write and/or review protocols, final development reports, batch records, standard operating procedures, and other technical reports to support regulatory filings.
  • Responsible for understanding and applying data generated from experiments used to modify/optimize formulations and product presentation.
  • Work effectively in a cross-functional matrix environment, with internal and external collaborators and proactively communicate with internal and external stakeholders.
  • Ensure all tasks are performed according to approved formulation development protocols and drug product batch records.
  • Author and/or review appropriate CMC sections of IND and BLA submissions.
  • Build, lead and manage a team and capabilities to support optimization and transfer of novel protein-based therapeutics to manufacturing activities.
  • Analyze products' biophysical properties to design formulation screening protocol that includes but is not limited to buffers, excipients and pH under liquid and lyophilized formulation.
  • Lead drug product process/platform design including but not limited to: thawing, formulation, mixing, filtration, material compatibility, components, filling and inspection.
  • Lead the design, development, and performance of short-term stability studies for defined formulation under regular and accelerated conditions.
  • Lead the design, development, and performance of clinical in-use compatibility studies for IV application
  • Lead the development/optimization of scale-up efforts to support drug product manufacturing.
  • Direct the development of technical transfer protocols and the transfer of drug product manufacturing processes into a cGMP drug product manufacturing facility
  • Provide on-going formulation related technical resource to R&D, PD and MFG
  • Manage and provide technical expertise to CMOs for DP manufacturing including: Working with DS manufacturing team to ensure proper transition to DP production; Establishing partnership with outside CMOs and overseeing DP manufacturing
  • Maintain knowledge of scientific trends and industry processes through readings, conferences, and seminars; review literature to enhance or improve study procedures and methods.
  • Author and/or review the preparation of and complete technical reports, data summaries and CMC related documents related to formulation, drug product and dose preparation.
  • Participate in the development of patent applications, regulatory documentation, and clinical documentation (for example, INDA, IMPD, Pharmacy Manual).
  • Participate in laboratory bench work as needed
  • Other duties and special projects, as assigned.

Qualifications:
  • Advanced Degree in Life Sciences, chemical engineering, biochemical engineering or related field, required
  • Minimum 10 years of relevant industry experience, required
  • Demonstrated technical proficiency in biologic drug substance and drug product formulation, required
  • Proven experience with protein chemistry and formulation development, required
  • Recognized expert in sterile drug product process development for protein therapeutics
  • Experience with relevant analytical technologies used in assessment of protein attributes and stability, including but not limited to: HPLC/UPLC, MFI, DSC, DLS, DSF, Viscosity, particulates characterization etc
  • Experience working with and leading cross functional teams such as CMC teams and clinical development teams
  • Excellent written, verbal communication and computer skills
  • Excellent analytical skills and problem-solving skills
  • Excellent organizational, time management, and multi-tasking skills
  • Ability to function independently and exercise good judgement, as well as provide thought leadership
  • Previous experience supporting regulatory filings is required
  • Ability to identify problems and solutions then act to resolve


Reporting Structure:

This position currently has supervisory responsibilities. This position reports to VP, Biopharmaceutical Development.

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