Director, Upstream Process Development (mRNA)
Emeryville, CA /
Process Development /
Full-Time
/ On-site
Pick a challenge that is bigger than your lifetime.
New ideas are all around us, but only a few will change the world. That’s our focus at Nutcracker. We are an early-stage company looking at mRNA and its production in a completely different way. We are challenging the conventional and merging both innovative science with engineering to not just save lives, but to improve the manufacturing and delivery of critical health solutions. Yes, as our name implies, we are working to crack some of the toughest scientific and engineering nuts out there. If you are driven to discover, create, and inspire something that moves science and technology forward, and lasts a lifetime and beyond, you’re ready to be a Nutcracker.
Director in Director, Upstream Process Development (mRNA) plays a critical role in bringing the therapeutic mRNA production capabilities of Nutcracker’s novel manufacturing platform to patients. This individual will be responsible for building process development strategies for DS production of our mRNA products. The ideal candidate will have a deep understanding of process development with expertise in mRNA drug substance in CMC activities with the ability to influence strategic direction, and prior experience in pharmaceutical operations related to mRNA vaccine field with proven track record is required. This position is based out of our Emeryville, CA headquarters.
Responsibilities:
- Design process development experiments for mRNA drug product to meet requirement of each project and program to deliver company’s milestones on time.
- Oversee and leads data driven decisions on mRNA (DS) production process development and optimization, phase-appropriate CMC readiness and MFG readiness.
- Participate cross-functional technical discussions as subject matter experts on overall mRNA (DS) production strategy on manufacturability of mRNA (DS) production, process optimization, scale up, and stability in line with industry standards for mRNA drug substances.
- Provide guidance on MFG DP operations to successfully resolve problems with MFG operational challenges and deviations.
- Actively contribute to authoring CMC sections of regulatory documents.
- Collaborate with Research, Engineering and AD/Quality to ensure the quality of the company's manufactured products and communicate appropriately to cross-functional teams and senior management.
Requirements:
- Candidate should have a B.S or M.S. or Ph.D. with minimum 12 – 15 (B.S), 10-12 (M.S) or 7-10 (Ph.D) years of experiences in biopharmaceutical manufacturing or biologics, and/or cell/gene therapies.
- Expertise in mRNA DS manufacturing for clinical programs with wider scope of administration/doses requirements.
- Experiences in authoring CMC sections for different filing and responding to RTQs and post filing commitment (especially early stage).
- Experiences in mRNA vaccine products and platforms is highly desirable.
- Deep understanding of current challenges associated with mRNA production in biopharmaceuticals and the impacts on efficacy/stability of DS.
- Proven track record of developing mRNA platform and drug substance designs that ensures the product quality.
- Great communication and leadership experience in working with cross-functional teams.
The expected salary range for this role is $184,000 to $240,000, based on candidate experience, education, location, and other job-related factors. Employees are also eligible to participate in benefits including Medical, Dental, Vision, Life Insurance, 401(k), PTO plan and employee stock options.
Nutcracker Therapeutics is an early stage life science company building a workplace where highly collaborative and diverse teams thrive. If your best work is performed in a fast-paced entrepreneurial work environment where meaningful work is mastered each day, we’d love to hear from you.
Nutcracker Therapeutics is an equal opportunity employer and values diversity, as such, we do not unlawfully discriminate on the basis of race, color, religion, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, physical or mental disability, medical condition (as defined under California law), veteran status, sexual orientation, gender identity, gender expression, sex or gender (which includes pregnancy, childbirth, breastfeeding, or related medical conditions), taking or requesting statutorily protected leave, or any other basis protected by law.
