Director/Senior Manager, Biopharmaceutical Development (CMC)

Location
Austin, TX, USA
Posted
Jan 17, 2021
Ref
159744
Discipline
Science/R&D, CMC
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 for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly experienced and dynamic professional to lead and direct chemistry, manufacturing, and controls (CMC) development and manufacturing strategies for new and mature products. This role requires significant knowledge and experience in the preparation of CMC regulatory submissions, response to agency questions, comments, IND updates, annual reports, and regulatory agency requirements for early and late product development phases.

This Director or Sr. Manager will be the program leader providing guidance and support to internal groups such as biopharmaceutical process and product development, analytical development, formulation development quality, manufacturing, supply chain and regulatory affairs. Your role as leader will extend to outside groups, such as contract manufacturing organizations and contract laboratories to ensure that products are manufactured in compliance with all applicable regulations and protocols. This role will be responsible for providing strategic input, conducting risk assessments and oversee preparation of CMC regulatory submissions. This position will require excellent technical, analytical, decision making and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams, contractors, and external regulatory agencies.

Job Responsibilities will include:
  • Participate in identifying, creating, and sustaining CMC processes to successfully support the growing pipeline of product candidates
  • Oversee Operations functions within CMC, including but not limited to defining specifications, trending and analyzing batch data, maintain internal and external CMC documents, and supporting and defining aspects of distribution and release management
  • Work within CMC and process development functions to help generate manufacturing summary reports to inform product, process, and analytical development and help identify and monitor product yields and/or product quality
  • Compile, review and approve high-quality CMC modules for development and marketing registration applications, annual reports, amendments, and supplements for submission, ensuring complete CMC content that meets current regional requirements and FDA/Health Authority questions
  • Manage efforts at contract service providers to support drug substance and drug product manufacturing, and development efforts as needed
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports
  • Assess and communicate CMC requirements to ensure all development activities are compliant with applicable regulations and guidelines
  • Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones
  • Serve as a CMC project contact with external and internal clients, as needed
  • Support the review of CMC content for accuracy, including data verification, clarity, consistency, and conformance to writing conventions, and present findings to management
  • Identify project issues and contribute to the development of alternative CMC development strategies

Qualifications:
  • Advanced degree in the Life Sciences or related field, required
  • Minimum of eight (8) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development
  • Experience with biological process development, analytical, formulation and drug product development required
  • Demonstrated experience with large molecule biologics and minimum two (2) years directly involved with CMC operation efforts
  • Experience in process or analytical development, qualification, and validation strategies, preferred
  • 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 currently has no supervisory responsibilities.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

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