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About the role
Key responsibilities & impact- Provide scientific and technical assistance in research and development of plasma-derived or recombinant proteins
- Oversee stability-related investigations, stability chambers, storage, delivery, and documentation of sample inventory
- Maintain a compliant stability program for licensed products and developmental projects
- Provide technical expertise and leadership in research, development, or manufacturing support
- Lead or represent the functional area on cross-functional teams
- Prepare and critically edit complex procedures and technical reports for IND or BLA inclusion
- Develop novel programs and alternative solutions to meet departmental objectives
- Lead problem-solving efforts and mentor/train staff
- Design, execute, and interpret novel, scientifically complex study programs
- Direct others in study execution and mentor them in experimental design
- Collect, review, and analyze stability data
- Generate, review, and approve stability documentation
- Author and review stability reports for annual product reviews and regulatory submissions
- Provide stability support for marketed and developmental products
- Maintain work areas according to company policies and industrial best practices
- Support research, developmental stability studies, and clinical or commercial manufacturing
- Identify, implement, and qualify equipment to meet best practices or regulatory expectations
- Lead projects and provide departmental and new-employee training
- Serve as subject matter expert during audits and inspections in the department manager’s absence
Requirements
What you’ll need- Completed PhD + 0-2 years of experience, MS + 8 years of experience, or BS + 10-11 years of experience in a relevant field such as Biology, Biochemistry, Chemistry, or Toxicology
- Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
- Strong ability to set and meet deadlines, multitask, and prioritize resources
- Advanced written and oral communication skills
- Experience leading or representing a functional area on cross-functional teams
- Ability to supervise up to eight scientific personnel
- Statistical data analysis, including SAS JMP or equivalent
- Proficiency with MS Office
- Technical report writing and attention to detail
- Technical knowledge sufficient to conduct and resolve stability investigations
- Knowledge of cGMP practices
- Sample management experience
- Experience monitoring and maintaining validated temperature-controlled units
- Knowledge of FDA and ICH stability-study guidelines
- Working knowledge of DCM, SAP, Fiori, Apogee Monitoring System, and TempTale Monitoring Devices
- Prior experience shipping biological samples
- Basic calculation skills and keen assessment skills
- Ability to maintain neat, accurate, complete, and timely records
- Ability to work independently with minimal supervision and in a team environment
- Ability to perform the physical and occupational demands of an office/laboratory environment, including lifting up to 50 lbs and using required PPE
Benefits
Comp & perks- Up to 8% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(k) match
- Tuition reimbursement
- Opportunities for professional growth and career progression