Associate Director, MSAT/External Manufacturing Management
Associate Director, MSAT/External Manufacturing Management
Posted on :
01-06-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
OPPORTUNITY
Mammoth is seeking an experienced and highly motivated Associate Director of MSAT to lead formulation and process development for our pipeline of mRNA-based therapeutics. This is a critical and hands-on leadership role within a start-up environment. The successful candidate will report to the Head of CMC and be responsible for global tech-transfer documentation readiness working cross-functionally to support early-phase development through clinical supply and partnering with external manufacturing organizations to bring first-in-human and subsequent programs to the clinic.
KEY RESPONSIBILITIES
- Strategic & Functional Leadership:
- Serve as the subject matter expert for mRNA-LNP tech transfer establishing internal capabilities and setting phase-appropriate development strategies
- Build the MSAT function from the ground updesigning systems workflows and documentation standards suitable for an early-stage company scaling for growth
- Partner closely with Process Development Analytical Quality Regulatory and Program Management to align technical and strategic plans.
- Project manage external stakeholders and high profile meetings (up to 10% of time)
- MSAT and Alliance Management:
- Design and optimize mRNA-LNP formulations suitable for parenteral administration with a focus on stability manufacturability and delivery
- Develop scalable phase-appropriate aseptic drug product processes including fill-finish operations cryogenic handling (as applicable) and cold-chain compatibility
- Assess and implement suitable container-closure systems (vials syringes) that meet regulatory and operational requirements
- CDMO Oversight & Tech Transfer:
- Lead selection and oversight of CDMO partners for fill-finish operations and drug product testing
- Drive technology transfer of processes and methods to external partners; provide technical oversight for engineering and GMP runs
- Accountable for batch record review and approval in accordance with regulatory guidelines
- Manage timelines budgets and deliverables in collaboration with internal stakeholders
- Regulatory & Compliance:
- Author and review the drug product portions of regulatory submissions (INDs/CTAs) including descriptions of manufacturing control strategies and stability programs
- Ensure compliance with cGMP and global regulatory requirements leveraging a risk-based phase-appropriate approach
- Serve as SME during regulatory interactions and inspections
- Team Building & Mentorship:
- Initially operate in a hands-on player-coach capacity with strong individual contributions
- Foster a collaborative accountable and mission-driven team culture
REQUIRED QUALIFICATIONS
- Ph.D. or M.S. in Pharmaceutics Chemical Engineering Biochemistry or related field with a minimum of 5 years (PhD) of sterile drug product development experience preferably with mRNA or other advanced modalities; minimum of 7 years with a masters degree; or 10 years with a bachelors degree
- Strong working knowledge of mRNA-LNP formulation cryogenic storage and cold-chain management
- Proven track record of advancing sterile injectable products into the clinic ideally within a fast-paced or resource-constrained environment
- Experience with fill-finish operations aseptic processing and external manufacturing oversight
- Excellent problem-solving communication and cross-functional collaboration skills
- Ability to work onsite or commute to our Brisbane CA location regularly
- Ability to work Pacific Time Zone if not located within the west coast
- Ability to travel internationally as needed
PREFERRED QUALIFICATIONS
- Entrepreneurial spirit and comfort operating in ambiguity; energized by building systems from the ground up
- Experience in early-phase biotech
- Familiarity with microfluidics-based LNP manufacturing or novel delivery platforms
BENEFITS
- Company-paid health/vision/dental benefits
- Unlimited vacation and generous sick time
- Company-sponsored meals and snacks
- Wellness caregiver and ergonomics benefits
- 401(k) with company matching
Base Salary Range: $167000 - $209000 per year
Actual base salary will be determined by relevant professional experience applicable skills and internal equity.
COMPANY
Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin Janice Chen and Lucas Harrington the companys ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks including base editing gene writing and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoths deep science and industry experience along with a robust and differentiated intellectual property portfolio have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies.
It is our policy and intent to provide equal opportunity to all persons without regard to race color religion political affiliation sex/gender (including gender expression/identity pregnancy childbirth and related medical conditions) marital status registered domestic partner status sexual orientation age ancestry national origin veteran status disability medical condition genetic characteristics and/or any other basis protected by law. This policy covers all facets of employment including but not limited to: recruitment selection placement promotions transfers demotions terminations training and compensation.
Mammoth Biosciences requires that all employees be vaccinated against COVID as a condition of at-will employment with exceptions for medical or religious reasons in compliance with local state and federal law.
Required Experience:
Director
Employment Type
Full-Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
