Analytical - Drug Formulation Careers

Manager of Pharmaceutical Clinical Manufacturing, Facilities and Equipment

 

Company Overview:

 

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

 

Job Overview:

 

In collaboration with the Velesco scientist leading new drug development projects, colleagues in Kalamazoo and clients, the successful candidate will:

 

Manufacturing

 

  1. Oversee the scheduling of clinical manufacturing campaigns
  2. Prepare and gain approval of the necessary batch records and other cGMP documentation as required.
  3. Manage the preparation of the facility, equipment, materials and documents for manufacture.
  4. Lead the team in executing manufacturing activities.
  5. Manage the post manufacture operations e.g. document review and cleaning

 

Facilities and Equipment

 

  1. Purchase and conduct the validation of equipment
  2. Schedule, organize and supervise the bi-annual facility shutdowns
  3. Undertake/Oversee the following facility and equipment related activities:
    1. Environmental monitoring
    2. Pest control program
    3. Cleaning of the facility
    4. Repair and maintenance
    5. Calibration and validation

 

Education, training, experience:

 

A bachelor’s degree (or equivalent) with 7+ 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

 

Interested applicants should send resume/cover letter to info@velescopharma.com

 

 

Analytical Chemist – Job Overview:

 

This position involves the development and validation of pharmaceutical analytical methods in Velesco Pharma’s development laboratories.  Additionally, the successful candidate will lead the transfer of analytical methods, along with release and stability testing of clinical study supplies in our cGMP QC laboratory

 

Based primarily in the Plymouth, MI facility the role will entail frequent (1-2 times a month) multi-day trips to our cGMP facility in Kalamazoo.

 

Education, training, experience:

 

A minimum of 5 years’ experience in a pharmaceutical analytical chemistry laboratory, including experience with operating, maintaining, and troubleshooting HPLC systems , method development, method validation and stability testing programs.   Familiarity with Agilent HPLC systems and Chemstation/Empower software is an advantage. Experience with dissolution method development/execution is preferred.  Experience handling and weighing small quantities of material utilizing a microbalance, familiarity with writing and maintaining SOPs, high quality lab notebook documentation, and ability to write high quality scientific reports is required. 

 

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 to recognize and solve laboratory/data issues.  Exhibits good writing, communication and time-management skills and is proficient in Microsoft Word, Excel, Outlook, and similar programs. Able and willing to work in a team environment and participate in team activities.

 

Education Required: BS or MS Degree in Chemistry or related field.

Please send qualified resume to info@velescopharma.com

 

Salary: Negotiable

 

Benefits: Health & Dental Insurance, 401K

 

Velesco is an Equal Opportunity Employer.

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