BioAgilytix · 1 day ago
Senior Director, CMC
Durham, NC
Full-time
Onsite
Director/Executive
10+ years expBioAgilytix is a company focused on premier science and the impact it has on the world. The Senior Director of CMC will provide strategic oversight of Chemistry, Manufacturing, and Controls operations, managing teams and ensuring client satisfaction while achieving corporate revenue targets.
BiotechnologyLifestyle
Responsibilities
Provide strategic and managerial oversight of Chemistry, Manufacturing and Controls (CMC) operations including overseeing pharmaceutical laboratory method development, validation, and sample analysis in support of peptides, hormones and proteins (biomarker, cell-based, PK, immunogenicity, immuno-, and enzymatic assays), project management, and laboratory material/instrument management
Manage CMC testing operations departments through a team of functional managers and front-line supervisors
Direct, develop, and provide leadership and technical mentoring to staff to establish operational procedures, solve operational problems, and develop technical protocols
Work with senior management on the planning and development of operational policies, objectives and initiatives
Provide client satisfaction, employee satisfaction, quality and on-time delivery of BioAgilytix services
Achieve corporate revenue targets
Align objectives and resources across all BioAgilytix teams and projects, in particular assuring that resources allocated to a given functional group match the workload priorities
Meet client’s expectations/timelines
Provide advice, directions and any required help with preparation and presentation of proposals to the clients
Monitor the production of regulatory documents generated within CMC Operations, in collaboration with Quality teams
Maintain contact with the Sales and Marketing team to achieve project objectives and establish realistic timelines
Other duties as needed
Qualification
Required
Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 14 years' experience in a scientific laboratory environment
Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years' experience in a scientific laboratory environment
PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with no less than 10 years' experience in a scientific laboratory environment
Ability to guide the development of immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
Ability to work effectively within team to meet objectives under time constraints
Ability to take direction well and multi-task
Acute attention to detail and organizational skills
Excellent oral and written communication skills
Proficiency in MS Excel and Word
Demonstrated experience serving in a supervisor role and leading teams
Knowledge and application of regulatory guidance
Experience working in GMP environments and demonstrated knowledge of GMP regulations
Experience in leading cross functional teams, Laboratory operations, and product/project management in the pharmaceutical/biotechnology industry
Understanding of GMP regulations and knowledge of the FDA and EMEA guidelines and industry standards
Benefits
Medical Insurance (HDHP with HSA; PPO)
Dental Insurance
Vision Insurance
Flexible Spending Account (medical; dependent care)
Short Term Disability
Long Term Disability Life Insurance
Paid Time Off (4 weeks per year)
Parental Leave
Paid Holidays (9 scheduled; 5 floating)
401k with Employer Match
Employee Referral Program
Company
BioAgilytix
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development.
1001-5000 employees
H1B Sponsorship
BioAgilytix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (8)
2023 (8)
2022 (6)
2021 (9)
2020 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2016-02-22Acquired
Leadership Team
Davide Molho DVM
Chief Executive Officer
Maureen Marchek
Chief Financial Officer
Company data provided by crunchbase