Belcher Pharmaceuticals

Employment

Belcher Pharmaceuticals, a premiere generic pharmaceutical company, has exciting opportunities and positions available for industry professionals. At Belcher Pharmaceuticals, employees have the benefit of working in a team environment. Employees will have the chance to receive rewards based on performance and contributions. Our company is committed to expanding its knowledge of prescription products and encourages our employees to learn through existing and new products and solutions.

At Belcher, we recognize that success is not magic. It comes on the back of hard work and the passionate pursuit of excellence our people bring with them. Here, we encourage collaboration and are constantly seeking ways to create new value. At Belcher, we believe in:

  • Not limiting your thinking
  • Thinking and acting like an owner
  • Taking responsibility for your work and in being accountable for the results
  • Growing the company and continuously improving everything we do
  • Respecting and caring for every individual and building genuine relationships
  • Providing the resources people need to be their best

We are currently accepting applications for several positions. Belcher Pharmaceuticals is proud to have created a diverse working environment and is an equal opportunity employer. Until we build our online application process, you may send resumes to jobs@belcherpharma.com and reference the position name in the subject line.

Current Job Openings:

Job Title: Sr. Regulatory Affairs Associate

Job Duties:

  • Provide input on regulatory requirements for development and approval of new and generic drug products
  • Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations / interpretations
  • Responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies including U.S.F.D.A., Health Canada, European Medicines Agency (EMA); and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Ensure regulatory information in submissions meets U.S.F.D.A. or other regulatory agency’s standards
  • Researches, analyzes and communicates regulatory information and determines acceptability of data procedures, and other product-related documentation presented in support of product registration
  • Ensure compliance to 21 C.F.R regulations and standards; evaluate and assess product / process changes and deviations from regulatory commitments;
  • Provide guidance for regulatory submissions; category strategy and advice to project teams; and resolve relegated regulatory issues.
  • Review protocols like method validation, dissolution profiles, impurity profiles and cleaning method validation consistent with FDA and other regulatory agencies.
  • Review documentation including SOPs, material specifications, validation reports and stability protocols and write regulatory SOPs
  • Review labeling, advertising and promotional labeling to ensure compliance to regulatory policies and guidelines
  • Review and prepare responses to inquiries from regulatory authorities relating to product registrations
  • Prepare facility, drug substances and devices licenses documents submitted to various states in the U.S.

Work Schedule: Mon – Fri; 9:00a.m.-6:00p.m., 40 hours per week

Education:
Bachelor of Science (or its foreign equivalent) in Biochemistry or a related science discipline.

Experience: 60 months in the job offered or as an Assistant Manager (QA); Sr. Executive (QA); Executive (QA); QA Chemist or closely related job title. 12 months of the 60 months experience to include, experience in:

  • Responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies including U.S.F.D.A., Health Canada, European Medicines Agency (EMA); and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Ensure compliance to 21 C.F.R regulations and standards; evaluate and assess product / process changes and deviations from regulatory commitments;
  • Review protocols like method validation, dissolution profiles, impurity profiles and cleaning method validation consistent with FDA and other regulatory agencies.
  • Review and prepare responses to inquiries from regulatory authorities relating to product registrations

Employer Name: Belcher Pharmaceuticals, LLC 

Work Location: 6911 Bryan Dairy Road, Suite 210
Largo, FL 33777

Mail Resume: Mr. Shyam Busireddy, COO
Belcher Pharmaceuticals, LLC
6911 Bryan Dairy Road, Suite 210
Largo, FL 33777

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Job Title:                   
Senior Chemist (Full-Time) (Multiple Positions)

Job Duties:

  • Perform chemical analysis by using various analytical techniques such as Wet Analysis, Spectrophotometric Analysis, Thin layer Chromatography, and High Performance Liquid Chromatography.
  • Analyze pharmaceutical raw materials, in-process samples, intermediates and drug substances as per approved standard test methods.
  • Provided support to process development and quality control departments in respective projects. 
  • Development of analytical methods with the reference of various scientific journals and pharmacopeias. Preparing and reviewing protocols, reports, SOP’S, specifications, test procedures with documentation.
  • Assist in chromatographic methods development, analytical method validations, basic troubleshooting, maintain and calibrate equipment as per standard operating procedures.
  • Write / reviews analytical method validation protocols, reports and preparation of SOP’s, specifications, standard test procedures.
  • Audits and verifies results, including but not limited to calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
  • Lead all analytical technology transfer activities as required by the respective projects.
  • Compile necessary documentation to support regulatory submissions such as Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDA) as required.

Supervision:              Supervise 1 (one) Chemist

Work Schedule:        Mon-Fri; 8:00am-5:00pm; 40 hours per week 

Education:                 Bachelor’s degree (or its foreign equivalent) in Chemistry.

Experience:               

60 months of experience in the job offered or as a Research Associate, Sr. Executive, Executive, Jr. Manager, Jr. Scientist, Associate Scientist, Chemist, or closely related occupation. 12 months of the 60 months experience must include, experience in:

  • Provided support to process development and quality control departments in respective projects.  
  • Development of analytical methods with the reference of various scientific journals and pharmacopeias. Preparing and reviewing protocols, reports, SOP’S, specifications, test procedures with documentation.
  • Lead all analytical technology transfer activities as required by the respective projects.
  • Compile necessary documentation to support regulatory submissions such as Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDA) as required.

Employer Name: Belcher Pharmaceuticals, LLC

Work Location: 6911 Bryan Dairy Road, Suite 210
Largo, Florida 33777

Mail Resume: Mr. Shyam Busireddy, COO
Belcher Pharmaceuticals, LLC
6911 Bryan Dairy Road, Suite 210
Largo, Florida 33777

 


Our Advantage
  • Quality. We manufacture a wide range of superior products - from tablets and capsules to pellets and powders - using the most advanced equipment at our modern facilities.
  • Flexibility. We customize product formulations and packaging configurations in both small and large volumes to meet every customer's individual needs.
  • Reliability. We provide on-time delivery, exceptional service and competitive pricing, helping our customers bring world-class products to millions of consumers globally.