Technical and Regulatory Chemistry Manufacturing and Controls

Heluna Health and the Infant Botulism Treatment and Prevention Program (IBTPP) of the California Department of Public Health (CDPH) invite applications for the position of Technical and Regulatory Chemistry, Manufacturing, and Controls (CMC) Scientist. IBTPP is a unique public health/public service orphan drug program in the CDPH. IBTPP is the creator, sponsor, producer, and distributor worldwide of the licensed public service (i.e., not-for-profit) orphan drug, BabyBIG®. BabyBIG treats the orphan (rare) disease known as infant botulism, a life-threatening, paralytic, infectious disease. The program interacts with federal and state government agencies, private contractors, hospitals, physicians, and infant botulism families nationwide. The IBTPP consists of a small team of dynamic, dedicated professionals who work on the diagnosis, treatment and prevention of infant botulism and related disorders. Additional program information may be found at:

The Technical and Regulatory CMC Scientist will manage multiple contract development and manufacturing organizations (CDMOs),contract research organizations (CROs), and an in-house team. The CMC Scientist will manage regulatory CMC activities, specifically manufacturing and quality control through all stages of the lifecycle for BabyBIG® including supply chain. The team will be responsible for executing CMC strategies. The CMC Scientist will be responsible for managing the activities of CDMOs and CROs, including review and approval of CMC- and quality-related U.S. Food and Drug Administration (FDA) correspondence and regulatory submissions for BabyBIG®. The individual will be expected to actively participate in cross-functional governance teams for topics relevant for BabyBIG®. The individual will need to successfully manage multiple projects in a fast-paced and results-oriented environment. The individual will actively lead and/or actively participate in cross-functional teams to improve and simplify complex business processes. Effective communication skills will be critical to overall success. 

Remote position (may change in the near future to in-office due to state regulations/requirements). 

ESSENTIAL FUNCTIONS

• Manages multiple CDMOs, CROs, and an in-house team to execute CMC regulatory strategies
• Provides advice to manufacturing and quality teams on complex technical and regulatory CMC topics
• Partners closely with senior leaders and key stakeholders to help working teams navigate emerging issues
• Works collaboratively with members of the CDPH-contracted regulatory affairs CRO to ensure alignment on regulatory strategies and priorities are aligned
• Reviews documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the need of the company
• Engages in Technical and Regulatory CMC discussions and interactions with health authorities and regulatory CRO to facilitate review and approval of BabyBIG regulatory submissions at the expert level
• Leads and/or actively participates in cross-functional teams to improve and simplify business process
• Provides interpretation of regulatory guidance documents, regulations and directives and advises Manufacturing and Quality Control and Assurance and groups regarding their applicability and impact on internal programs. 
• Effectively manages resources to ensure business priorities are met.
• Mentors and develops their team.

JOB QUALIFICATIONS

• Ability to work independently and thrive in a dynamic environment
• Strong knowledge of current US regulations pertaining to drug/biologics development and licensed biologics
• Experience in working with external CDMOs and/or CROs and managing CMC-related outsourcing activities
• Exceptional written and oral communication
• High level analytical and problem-solving skills, with the ability to critically evaluate scientific literature, interpret data, and drive data-driven decision making; experience with managing multi-disciplinary teams

EDUCATION/EXPERIENCE 

• PhD degree in a scientific/engineering discipline
• 10+ years of experience in the pharmaceutical/biotech industry
• 8+ years of experience in biologics-focused Technical and Regulatory CMC 
• Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up, or regulatory registration of products

CERTIFICATES/LICENSES/CLEARANCES

• Regulatory Affairs Certification (RAC) or CMC Certified Professional (CMCCP)

  PHYSICAL DEMANDS

• Stand Frequently
• Walk Frequently
• Sit Frequently
• Handling / Fingering  Occasionally
• Reach Outward Occasionally
• Reach Above Shoulder  Occasionally
• Climb, Crawl, Kneel, Bend  Occasionally
• See Constantly
• Taste/ Smell  Not Applicable

KEY

Not Applicable = Not required for essential functions

Occasionally = (0 - 2 hrs/day)

Frequently = (2 - 5 hrs/day)

Constantly = (5+ hrs/day)

WORK ENVIRONMENT

Remote position (may change in the near future to in office due to state regulations/requirements). 

ADDITIONAL INFORMATION

This position may require travel both within California and out of state to confer with Heluna Health, CDPH staff, or regulatory contractors. When necessary, the incumbent must be able and willing to travel.

EEOC STATEMENT

It is the policy of Heluna Health to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable 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)