Manager, Manufacturing & CMC Operations

Birmingham, United States

BioCryst Pharmaceuticals

Posted on: January 14, 2021

Closing: February 13, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in Japan and the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.

ROLE SUMMARY:

As the Manager of Manufacturing & CMC operations, this person will oversee CMC operational plans of programs within BioCryst’s development portfolio ensuring alignment with the strategic and functional objectives across R&D, Commercial and Supply Chain Operations. This person will provide knowledge-based coordination and management for projects to successfully expedite product development and regulatory approvals to provide much needed therapies to patients suffering from rare and orphan diseases.

 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide project leadership of manufacturing services, supporting business relationships, and leading cross-functional CMC teams of technical and functional experts as required; services covered include drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical methods development and validation, technology transfer and scale-up, process characterization and validation.
• Participate on global and regional cross-functional drug development project teams, as required, to represent CMC Development with both a strategic and operational focus
• Ensure the execution of drug development project strategies and operational plans that integrate the CMC development strategies and operational plans with those of other functions in order to expedite successful product development, regulatory approvals and commercialization;
• Apply sound scientific judgment to identify, communicate and address development challenges and delays.
• Provide oversight on CMC development program budgets and work collaboratively with finance to ensure alignment with strategic and operational plans.
• Implement strategies for project accelerations without risk to quality
• Ensure that the cGMP compliant policies, processes, procedures and best practices are consistently executed across the manufacturing operations
• Troubleshoots and resolves issues impending deliverables; proactively demonstrates the ownership to achieve deliverables
• Maintain a contemporaneous working knowledge in cGMP requirements
• Support the management of operational, budgetary, and financial responsibilities and activities of the development and manufacturing operations with our established suppliers
• The incumbent in this position has primary responsibility of overseeing program specific external manufacturing while ensuring cGMP compliance
• Other duties that may reasonably be assigned from time to time by the company

 

EXPERIENCE AND QUALIFICATIONS

• Minimum of 5 years’ experience in the pharmaceutical/biotechnology industry working in CMC product development required with demonstrated experience in at least one of the following areas (process, product or analytical development activities) with knowledge of global CMC regulatory requirements
• BS Degree required with an MS Degree or PhD in a life sciences discipline preferred
• Experience in bringing development candidates through clinical development. Late stage clinical development, filing, approval, and commercialization experience is a plus
• Plan program specific pharmaceutical production operations, technical operations and production services in alignment with the company’s overall CMC operational plans and strategy.
• Travel is up to 25%, as needed

 

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

BioCryst Pharmaceuticals

Posted on: January 14, 2021

Closing: February 13, 2021

Salary($): Undisclosed

Position Type: Full Time

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Career Focus: Manufacturing, CMC

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