Career Opportunities with Velesco Pharma
Manager of Pharmaceutical Clinical Manufacturing, Facilities and Equipment
Velesco Pharma is a contract research and manufacturing organization providing formulation, analytical and cGMP clinical supplies to clients in the pharmaceutical/biotech industry. Velesco is a high growth organization founded and staffed by pharmaceutical industry veterans. The successful candidate will be working in a dynamic flexible environment with an opportunity to learn and take on greater responsibility. This role is based at Velesco’s cGMP pharmaceutical clinical manufacturing facility in Kalamazoo, MI.
In collaboration with the Velesco scientist leading new drug development projects, colleagues in Kalamazoo and clients, the successful candidate will:
- Oversee the scheduling of clinical manufacturing campaigns
- Prepare and gain approval of the necessary product specifications and batch records and other cGMP documentation as required.
- Manage the preparation of the facility, equipment, materials and documents for manufacture. Ensure the required materials (API, excipients and packaging) are purchased, tested and released.
- Supervise and support operators and technicians in executing manufacturing activities.
- Manage the post manufacture operations e.g. document review and cleaning
Facilities and Equipment
- Identify the need for, purchase and conduct the validation of new equipment
- Schedule, organize and supervise the bi-annual facility shutdowns
- Undertake/Supervise the following facility and equipment related activities:
- Environmental monitoring
- Pest control program
- Cleaning of the facility
- Repair and maintenance
- Calibration and validation
Education, training, experience:
A bachelor’s degree (or equivalent) with 5+ years work experience in a GMP pharmaceutical drug product manufacturing environment. Experience in the supervision of manufacturing teams and expertise in the manufacture and packaging of liquid and semi-solid pharmaceutical products. An understanding of facility and equipment qualification/validation, clinical study packaging and labeling and/or solid product development is desirable.
Must be self-motivated, possess good interpersonal skills, able to independently handle a wide variety of work assignments and meet tight timelines. Candidate will work in a fast changing environment and needs good judgment and awareness. Exhibits good writing, communication and time/project management skills and is proficient in Microsoft Word, Excel and similar programs. Able and willing to work in a team environment and participate in team activities.
Salary: Competitive base salary plus bonus
Benefits: Health & Dental Insurance, 401K
Velesco is an Equal Opportunity Employer.