Senior Director, CMC

BioAgilytix • Durham, NC

1d

About The Position

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

Requirements

• Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 14 years’ experience in a scientific laboratory environment; or
• Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years’ experience in a scientific laboratory environment; or
• 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

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees