JOB TITLE: Senior Manager, External Manufacturing Operations

LOCATION: Remote - candidates based in the following states will be considered: IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, KY, NJ or WA.

REPORTS TO: Director, External Manufacturing

SALARY RANGE: $179,000 to $202,000. The midpoint of the range is $191,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Senior Manager of External Manufacturing Operations to lead the management, implementation, and execution of our CMC strategy at CDMOs. If you are a highly motivated and experienced GMP manufacturing professional with a passion for developing and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team.

KEY RESPONSIBILITIES

• Manage operational and technical support of small molecule CDMOs to deliver on late phase clinical and commercial production.
• Lead CDMOs to implement CMC strategy in manufacturing including but not limited to efforts to optimize manufacturing processes, implement process changes, and reduce manufacturing costs.
• Provide on-site CDMO oversight, as needed, to accomplish clinical and routine, commercial production goals
• Provide SME impact assessments on deviation investigations, support CAPAs, and manage proactive initiatives and change controls, as required.
• Lead review and approval for technical reports, risk assessments, batch records, SOP’s, etc. required for cGMP manufacturing. 
• Develop, track, and monitor production data for CMO during clinical manufacturing and PPQ to mature to continued process verification (CPV) during commercial manufacturing.
• Represent External MFG / MSAT on cross functional teams (internal and external) for late stage / commercial CDMO. Act as the internal project team lead for CDMO.
• Ensure operational robustness and efficiency through management and tracking of manufacturing metrics and KPIs 
• Support authoring and review of CMC sections of health authority submissions. Provide immediate response support, as required
• Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches
• Other duties as assigned.

ABOUT AURION BIOTECH 

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company. 
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. 
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments. 

Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• B.S, M.S, or Ph.D. degree in chemistry, chemical engineering or related, scientific discipline required.
• 10+ years of experience w/ a B.S.; 7+ years of experience w/ M.S. or higher.
• 5+ years of experience, in process chemistry/development, MS&T, and/or External Manufacturing for small molecules required. 
• cGMP manufacturing experience required. 3+ years preferred.
• Experience managing production at CDMOs required. 3+ years preferred.
• Experience with late-stage clinical enabling, PPQ and commercialization activities for small molecules preferred

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Experience managing manufacturing activities and CDMOs during clinical/commercial cGMP manufacturing. 
• Strong understanding of cGMP regulations and process chemistry.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
• Experience authoring and reviewing protocols and reports that support GMP manufacturing, validation, and regulatory (BLA/MAA/etc) filings. 
• Strong analytical and problem-solving skills, with the ability to apply scientific and engineering principles to complex technical problems and data trending.
• Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment.
• Proficient use of MS Office products, JMP or other data analysis software proficiency is a plus
• Travel required up to 20%