Sr. Manager - Chemistry, Manufacturing & Controls (CMC)
Molecular Templates (MTEM) is a clinical-stage biopharmaceutical company targeting a variety of cancers through the development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.
Molecular Templates is seeking a highly experienced and dynamic professional to oversee and direct all chemistry, manufacturing and controls (CMC) regulatory and manufacturing strategies for new and mature products. This Sr. Manager will provide guidance and support to internal groups such as quality, manufacturing, supply chain and regulatory affairs, as well as to outside groups, such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations and protocols. Additionally, this role will be responsible for providing strategic input and risk assessments and oversees the preparation of CMC regulatory submissions. This position will require excellent technical, analytical and problem-solving skills, along with the 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 function to help generate manufacturing summary reports to inform product and process development and help identify and monitor product yields and/or quality.
- Compile, review and approve high-quality CMC modules for development and marketing registration applications, amendments, and supplements for submission, ensuring complete CMC content that meets current regional requirements and FDA/Health Authority questions.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports. Assess and communicate CMC regulatory 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.
- Supporting 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 Regulatory strategies.
- Advanced degree in the Life Sciences or related field, required
- Minimum of six (6) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development
- Demonstrated experience with large molecule biologics and minimum two (2) years directly involved with CMC operation efforts.
- Experience in managing quality systems and program management 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 in order to drive results and meet company objectives
- Ability to function independently and exercise good judgment, as well as in a team-based environment
- Minimal travel required
This position currently has no supervisory responsibilities. This position reports to VP, Manufacturing.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.