Senior Director of Manufacturing
Emeryville, CA /
Manufacturing /
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.
In this role, the Sr. Director of Manufacturing will lead the qualification and operation of a clinical GMP manufacturing suite housing our novel microfluidic based manufacturing systems (NMU – Nutcracker Manufacturing Unit). The GMP manufacturing suite will be used for the advancement of pipeline assets and drive to a commercial-stage biotech company. This role will be responsible to support development and lead implementation of our manufacturing processes, as well as material production from early through late stage clinical. This role will lead all manufacturing related interactions with US and international health authorities, assuring that manufacturing strategy, management of network of NMUs and scale-out activities are aligned and well-balanced from the perspectives of capital efficiency, corporate risk, and regulatory objectives.
The incumbent will build a high-quality Manufacturing and MSAT (Manufacturing Sciences and Technology) team of exceptional individuals responsible for building-out of novel GMP manufacturing processes, driving right-first-time execution, leading investigations and productivity opportunities, and optimizing resource models.
Responsibilities:
- Facility qualification and operation of a clinical GMP Manufacturing suite within the company’s Emeryville headquarter location. Assure strategy for operational and GMP readiness including documentation and validation.
- Hire, train and cultivate a strong and nimble Manufacturing and MSAT department.
- Define the manufacturing strategy for GMP operations in an early-stage biotechnology disruptive innovator. Work with seasoned people to define and deliver supplies for nonclinical and clinical studies.
- Implementation of manufacturing management systems.
- Devise strategy and manage manufacturing process development activities and drive flexibility in supply to support lead candidate selection.
- Develop and maintain a comprehensive, integrated Manufacturing strategy in collaboration with internal colleagues and build Manufacturing capabilities to support CMC and Clinical activities.
- Drive productivity and operational excellence opportunities to optimize manufacturing cycle time and efficient use of resources.
- Cultivate strong, credible relationships with health authorities as well as strategic partnerships and alliances with top-tier global pharmaceutical companies to achieve business growth objectives.
Requirements:
- A minimum of 10 years manufacturing management experience in the biotech industry with biologics expertise including successful product commercialization.
- Demonstrated success leading qualification of GMP manufacturing facilities.
- Expertise in manufacturing biologics and/or complex therapeutics in a highly regulated environment.
- Must bring relentless entrepreneurial drive to vastly accelerate highly automated biotech industry GMP manufacturing.
- Experience with FDA inspections and compliance requirements for regulatory filing.
- Scientific and technical acumen in the areas of process development/drug development.
- Outstanding interpersonal, communication and negotiation skills necessary to build strong, cross-functional internal relationships within a highly collaborative team, as well as with external stakeholders, such as regulatory authorities, and global pharmaceutical partners.
- Develop an organization that strives for operational excellence with emphasis on: right first time, eliminating waste, reducing cycle time, understanding and reducing variation, reducing risk, continuous improvement, and management oversight.
- Outstanding problem-solving and analytical skills coupled with maturity, confidence, and strong emotional intelligence.
- An unwavering commitment to safety, ethics, integrity, and building a quality culture.
- A bachelor’s degree in biology, chemical engineering, chemistry or engineering, preferably with an advanced degree (MS, Ph.D.).
The expected salary range for this role is $220,000 to $285,000, 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.
