The CMC Manager/Director will initially work under the direction of the current CMC leader, who is a consultant to Acumen. The CMC Manager/Director will assume responsibilities for the management of CMC development and manufacturing activities over time, and Acumen’s intention is that the CMC Manager/Director will be a leadership track position.
The CMC Manager/Director will work closely with peers in Clinical, Finance, Non-clinical, Quality, Non-clinical, Project Management and Research functions and will be jointly responsible for effective CMC support of cross-functional activities.
Travel within the US will be required. Travel outside of the US may be required in the future.
Location: Carmel, IN with potential to work remote during 2021. (relocation possible for qualified candidates)
ROLE AND RESPONSIBILITIES:
Current CMC development and manufacturing activities include:
- Production planning for ACU193 Drug Substance, Drug Product and Diluent; management of contract manufacturers
- Drafting, review and approval of CMC documentation including batch records, SOPs, work authorizations, CMC sections of regulatory submissions and CMC-related presentations
- Participation in strategy planning and budgeting processes; development of CMC plans for activities, resources, budgets and projected timelines; management and reporting of progress against plans and budgets
- Analytical and process data collection, review and analysis; communication of scientific assessments of development and production results and events
- Representation of Acumen and the ACU193 function in interactions with outside parties such as development partners and regulatory authorities
Future CMC development and manufacturing activities are anticipated to include:
- Hiring and development of staff
- Planning and management of process development and formulation development projects
- Planning and management of BLA-enabling validation and related CMC activities
- Planning and management of IND-enabling CMC activities for pipeline programs
- Selection and management of contract manufacturers and other external service providers
- Participation in the development and operation of enterprise scale software-based systems
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
The candidate should have at least 10 years of experience in the management of GMP manufacturing and CMC development activities of monoclonal antibodies at contract manufacturing sites.
A Bachelor’s degree in a relevant discipline is required, and an advanced degree is preferred.
The candidate should have excellent written and verbal communication skills.
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
COMPENSATION AND BENEFITS:
Competitive base salary, annual incentive bonus and company stock options. Package details based on qualifications and track record of performance.
Competitive benefits package including health, dental, vision, life insurance and 401K.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals, Inc., is a privately held company with offices in Charlottesville, VA and Carmel, IN. Acumen is developing targeted therapies for the safe and effective treatment of Alzheimer’s Disease and related neurodegenerative diseases. Acumen’s lead program, ACU193, is a monoclonal antibody which binds to amyloid beta oligomers which are widely acknowledged to be major mediators of Alzheimer’s Disease pathology. Acumen plans to initiate human clinical studies of ACU193 in 2021 and is seeking to add key contributors to support the development of ACU193 and the growth of the company.
Acumen Pharmaceuticals, Inc., is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Acumen prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Acumen conforms to the spirit as well as to the letter of all applicable laws and regulations.