Are you looking for a fast paced position in a rapidly growing pharmaceutical CDMO? We are currently seeking to fill a variety of positions at our Ann Arbor, Michigan facility. We are searching for talented and motivated individuals that would enjoy working in a team oriented, entrepreneurial company.
To apply, submit your resume and cover letter via email to firstname.lastname@example.org.
About the Opportunity
Nature and Scope
Responsible for leading day to day activities of formulation and process development activities associated with solid/liquid oral, parenteral, and topical/transdermal drug product development. Involves in trouble shooting of product development and manufacturing issues and supports IND/NDA and ANDA submission. Responsible for training of laboratory personnel in key formulation techniques/technologies and equipment. The individual will work closely with Technical Director of Pharma Product Development to ensure that project timelines are met and also assist in preparation of reports and regulatory documentation.
Areas of Expertise
- Expertise in preformulation activities including solid state characterization, and formulation and process development for conventional and novel drug deliveries.
- Experience in performance testing (especially dissolution theory and practice) and establishing specification for clinical trial materials.
- Experience in analytical methods and instruments, especially HPLC.
- Experience in regulatory filings including IND/NDA (505 b2 and 505b1), and ANDA(505j).
- Experience in managing multiple challenging projects and on time delivery.
Position Summary Responsibilities
- Provide technical leadership for the design and execution formulation product development studies and development of manufacturing process for all dosage forms such as solid/liquid orals, parenterals, topicals, etc.
- Manage daily activities of formulation laboratory and clinical trial material manufacturing suite to ensure that all the assigned projects are completed on time. Ensure that accurate and complete laboratory records are maintained in the group as required by company policy and Good Manufacturing Practices (cGMP) requirements.
- Lead formulation team in design and execution of laboratory experiments to perform preformulation activities, develop formulation, and optimize process for conventional and novel technologies.
- Expertise in granulation techniques, tableting and capsulation, blending and mixing, emulsification, coating and packaging.
- Review and approve R & D study protocols, DoE, and reports, manufacturing batch records.
- Reporting to the Technical Director, you will be responsible for managing projects with scientists, writing technical reports with high quality, and high on-time delivery
- Is capable of communicating credibility as a subject matter expert for product development domain
- Communicates effectively with clients and internally through written and oral presentation.
- Maintains high productivity of staff and mentors junior staff on technical issues with instruments or quality.
- Attend technical and management meetings and schedule work to align with department objectives.
- Plans and executes complex projects in the areas of formulation and related analysis, and complex formulation and process development.
- Ensuring compliance with government rules and regulations (FDA, cGMP, DEA, ICH, OSHA, etc.).
- Responsible for training junior scientists in key formulation techniques and essential formulation equipment.
- Perform any other tasks/duties as assigned by management.
- Ph.D. in pharmaceutical sciences 5+ years’ experience, or MS with 8+ years’ experience in formulation and process development.
- Excellent project management skills and the ability to effectively function in fast-paced, dynamic technical environment.
- CRO experience preferred.
- Experience working in a regulated environment under GMP and GLP requirements
- Experience managing a group of Ph.D., M.S., and B.S. chemists to complete technical projects on time and on budget
The position offers major benefits, competitive salary, and the opportunity to quickly advance to positions of higher responsibility.
Avomeen is an Equal Opportunity Employer.
Why Work for Us?
Avomeen is a full-service laboratory with unique analytical, product testing and formulation development expertise. Each member of the Avomeen team plays a critical and visible role in delivering high-quality scientific solutions, providing them with an opportunity to directly impact Avomeen’s success and advance their career. We make every effort to reward outstanding performance and provide interesting and scientifically challenging work. In order to ensure the success, development, and growth of our employees, we are committed to offering a variety of training opportunities.
Become Part of our Community
We recognize that our single greatest resource is our people, and our team members choose Avomeen not only to join our scientific knowledge-based community, but also to become part of a collaborative team committed to exemplary science and service to our clients. Successful Avomeen employees have a positive, client-centric outlook, and embody principles of integrity and leadership, as well as creativity, flexibility, and perseverance.