Job Description

Skye Bioscience takes pride in fostering a welcoming and inclusive community of passionate biotech enthusiasts who are united by their commitment to scientific excellence. Our workplace culture is built on fundamental values that guide everything we do: we champion supportive collaboration that enables breakthrough innovations, demonstrate purposeful and authentic passion in our pursuit of solutions, uphold unwavering integrity in all our actions, embrace personal and collective accountability, and maintain the highest quality standards in our research and development processes. These principles form the foundation of our approach to advancing therapeutic solutions and improving patient outcomes.

About the Role:

We are seeking a strategic and experienced VP of Chemistry, Manufacturing, and Controls (CMC) to lead our large molecule drug development programs and serve as our internal technical expert. As a key scientific leader, this role will spearhead all CMC activities and oversee outsourced manufacturing throughout the product development lifecycle. The position demands expertise in commercial manufacturing strategy, focusing on clinical and commercial demand, CDMO relationships, and supply risk management. The ideal candidate will drive CMC regulatory submissions while collaborating closely with Quality, Regulatory, Clinical, and R&D teams. This role requires a PhD and extensive pharmaceutical industry experience, combining technical expertise with strong leadership abilities to build and manage this critical function.

Responsibilities:

As the technical and scientific expert, the VP of CMC will lead and manage all CMC activities at the company and all outsourced manufacturing of products across the development life cycle, with responsibilities including:

Overall Management:

1. Communicate strategy, timelines and potential risks and issues to executive management.
2. Develop and manage CMC operational budget and timelines.
3. Interface closely with Quality, Regulatory, Clinical and R&D in development and execution of CMC strategy.
4. Set up CMC team meetings, cross-functional team meetings to ensure timely delivery of clinical supplies and documentation.

Strategy and Development:

1. Establish and oversee the implementation of the overall CMC strategy for all drugs in development.
2. Develop and implement a commercial manufacturing strategy considering future clinical and commercial demand, financial investment, CDMO relationships, inventory management and supply risk.
3. Develop plans to commercialization including process validation strategy, supply strategy and commercial manufacturing agreements.
4. Identify CMC-related risks and facilitate mitigation planning.

CDMO Selection and Management:

1. Lead outsourcing of manufacturing activities, contract drafting and negotiation for drug substance manufacture, formulation development and drug product manufacture.
2. Oversee manufacture of cGMP drug substance and product manufacture, labeling & packaging, including review and approval of batch records.
3. Oversee sourcing, planning and distribution of manufacturing equipment, raw materials, APIs, and packaging.
4. Oversee analytical method development, review results, QC and approval.
5. Visit vendors to oversee manufacturing campaigns and participate in audits.

CMC Regulatory:

1. Partner with Regulatory and contribute to the drafting of the CMC sections of regulatory submissions (e.g., INDs, CTAs, BLAs) and respond to any queries from regulatory authorities.

QUALIFICATIONS:

1. PhD in organic chemistry, pharmaceutics, chemical engineering or related field.
2. 15+ years experience in the pharmaceutical industry, directly related to above mentioned CMC activities, with sufficient exposure to both DS and DP manufacturing and troubleshooting.
3. Experience working, collaborating with, and managing CDMOs.
4. Strong knowledge of formulation options and troubleshooting.
5. Thorough understanding of cGMP for large molecule DS/DP and US regulatory environments; previous CMC submission experience preferred.
6. Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.
7. Excellent attention to detail and commitment to providing accurate, high quality work.
8. Strong organizational skills and the ability to manage multiple competing priorities.
9. Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.

Actual base salary for this role will take into consideration factors such as relevant experience, skills and qualifications for the role. Skye currently offers health benefits for eligible employees.

You must be authorized to work in the United States (required).

As an equal opportunity employer, Skye does not discriminate against any applicant or employee based on race, color, sex, sexual orientation, gender identity, marital status, religion, national origin, ancestry, age, disability, military or veteran status.

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