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:
 Chemist (Multiple Positions)

Job Duties:

  • Analyzes pharmaceutical raw materials, process intermediates and finished product stability samples, following approved standard test methods and procedures.
  • Performs chemical analysis work under supervision.
  • Documents the testing sequence of steps and test results as per STMs and SOPs.
  • Calculates and interprets test results as per test methods and specifications.
  • Notifies Supervisor of Out-of-Specification (OOS)/ Out- of-Trend (OOT) test results.
  • Operates, maintains, and calibrates equipment in assigned area.
  • Performs work related assignments as required by Management.
  • Reviews documentation.
  • Follows safety rules.
  • Conducts basic troubleshooting of equipment.
  • Coordinates as required the maintenance of lab equipment.
  • Manage R&D projects
  • Develop and validate Assay Methods, related compounds, characterization of impurity profiles of Active Pharmaceutical Ingredients and Finished Products; Assisting and support to file new Formulations for ANDA Submissions to FDA.

Work Schedule:
Full-time 40 hours per week; Mon to Fri 9:00 a.m. to 6:00p.m. or 11:00 a.m. – 8:00 p.m. (alternates week to week)

Education:
U.S. Master of Science in Pharmaceutical Chemistry. Master’s degree coursework to include, three semester credit hours in project management. 

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

---------------------------------------------------------------------------------------------------

Job Title: Quality Control Chemist

Job Duties:

  • Utilize understanding of Organic, Inorganic, Analytical and Physical Chemistry to design, develop and improve production processes of various drug formulations for Human and Veterinary use.
  • 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
  • Develop & Validate Analytical methods for R&D projects.
  • Support Formulation Development on R&D projects from conception to commercialization.
  • Develop & Validate Swab Methods for R&D and Commercial Projects.
  • Prepare and execute Method Validation Protocols for Assay, Dissolution, Related Compounds & Residual Solvents.
  • Conduct Drug-Excipient compatibility studies on new formulations to assist the formulation group in streamlining the formulation.
  • Conduct Dissolution testing (Single point and Profile study) on Tablets, Capsules and Suspensions.
  • General training of new employees in the Quality Control Department and training on new and existing equipment (HPLC, Gas Chromatography, KF Titrator, UV/Vis Spectrophotometer and Dissolution Apparatus).
  • Documentation and review of Analytical R&D Data.
  • Perform Blend Uniformity and Content Uniformity Assays for R&D and commercial products.
  • Assist and support in filing ANDA and NDA submissions to FDA.
  • Characterization of impurity profiles of Active Pharmaceutical Ingredients and Finished Products.
  • Conduct Forced degradation studies on Drug substances and Drug Products to develop stability indicating methods for Assay and Related compound determination.
  • Interface with formulation and Production team to respond to their needs.
  • Develop realistic physical/chemical specifications for finished formulations and Drug substances.
  • Work with Formulation to ensure that all products are formulated by strictly adhering to all process instructions to ensure consistent quality in each batch.
  • Develop measurements to ensure quality, accuracy, and efficiency in formulation by working with the formulation team.
  • Write SOPs, STMs, protocols, reports, and specifications.
  • Develop and implement Root Cause Analysis with QA assistance.
  • Work with supervisor in performing investigations for OOS & OOT.
  • Calibration, maintenance & troubleshooting of various equipment (HPLC, GC, KF Titrator, UV/Vis Spectrophotometer and Dissolution Apparatus).
  • Perform physical testing including hardness, thickness, weight variation, friability dissolution and disintegration.

Work Schedule: Full Time, 40 hours per week

Education:
Bachelor of Science (or its foreign equivalent) of Pharmacy.

Experience: 9 months experience in the job offered or as a Manufacturing Associate. 9 months experience to include, experience in working with different pharmaceutical equipment’s including UV spectrophotometer; and perform physical testing including hardness, thickness, weight variation, friability dissolution and disintegration

Employer Name: Belcher Pharmaceuticals, LLC 

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

12393 Belcher Road Suite 420 A and B
Largo, FL 33773

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


-----------------------------------------------------------------------------------------

Job Title: Quality Control Chemist

Job Duties:

  • Utilize understanding of Organic, Inorganic, Analytical and Physical Chemistry to design, develop and improve production processes of various drug formulations for Human and Veterinary use.
  • Develop & Validate Analytical methods for R&D projects.
  • Support Formulation Development on R&D projects from conception to commercialization.
  • Develop & Validate Swab Methods for R&D and Commercial Projects.
  • Prepare and execute Method Validation Protocols for Assay, Dissolution, related Compounds & Residual Solvents.
  • Conduct Drug-Excipient compatibility studies on new formulations to assist the formulation group in streamlining the formulation.
  • Conduct Dissolution testing (Single point and Profile study) on Tablets, Capsules and Suspensions.
  • General training of new employees in the Quality Control Department and training on new and existing equipment (HPLC, Gas Chromatography, KF Titrator, UV/Vis Spectrophotometer and Dissolution Apparatus).
  • Documentation and review of Analytical R&D Data.
  • Perform Blend Uniformity and Content Uniformity Assays for R&D and commercial products.
  • Assist and support in filing ANDA and NDA submissions to FDA.
  • Characterization of impurity profiles of Active Pharmaceutical Ingredients and Finished Products.
  • Conduct Forced degradation studies on Drug substances and Drug Products to develop stability indicating methods for Assay and Related compound determination.
  • Interface with formulation and Production team to respond to their needs.
  • Develop realistic physical/chemical specifications for finished formulations and Drug substances.
  • Work with Formulation to ensure that all products are formulated by strictly adhering to all process instructions to ensure consistent quality in each batch.
  • Develop measurements to ensure quality, accuracy, and efficiency in formulation by working with the formulation team.
  • Write SOPs, STMs, protocols, reports, and specifications.
  • Develop and implement Root Cause Analysis with QA assistance.
  • Work with supervisor in performing investigations for OOS & OOT.
  • Calibration, maintenance & troubleshooting of various equipment (HPLC, GC, KF Titrator, UV/Vis Spectrophotometer and Dissolution Apparatus)

Work Schedule: Full Time, 40 hours per week

Education:
U.S. Master of Science in Chemistry

Experience: Is employment experience required? Yes. 9 months experience in the job offered or as an Intern Chemist. Experience to include, 9 months experience in: performing description, identification, water content, assay and other tests on drug substances i.e. Active Pharmaceutical ingredient

Employer Name: Belcher Pharmaceuticals, LLC 

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

12393 Belcher Road Suite 420 A and B
Largo, FL 33773

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

 --------------------------------------------------------------------------------------

Job Title: Quality Control Chemist

Job Duties:

  • Utilize understanding of Organic, Inorganic, Analytical and Physical Chemistry to design, develop and improve production processes of various drug formulations for Human and Veterinary use.
  • Develop & Validate Analytical methods for R&D projects.
  • Support Formulation Development on R&D projects from conception to commercialization.
  • Develop & Validate Swab Methods for R&D and Commercial Projects.
  • Prepare and execute Method Validation Protocols for Assay, Dissolution, related Compounds & Residual Solvents.
  • Conduct Drug-Excipient compatibility studies on new formulations to assist the formulation group in streamlining the formulation.
  • Conduct Dissolution testing (Single point and Profile study) on Tablets, Capsules and Suspensions.
  • General training of new employees in the Quality Control Department and training on new and existing equipment (HPLC, Gas Chromatography, KF Titrator, UV/Vis Spectrophotometer and Dissolution Apparatus). 
  • Documentation and review of Analytical R&D Data.
  • Perform Blend Uniformity and Content Uniformity Assays for R&D and commercial products.
  • Assist and support in filing ANDA and NDA submissions to FDA.
  • Characterization of impurity profiles of Active Pharmaceutical Ingredients and Finished Products.
  • Conduct Forced degradation studies on Drug substances and Drug Products to develop stability indicating methods for Assay and Related compound determination.
  • Interface with formulation and Production team to respond to their needs.
  • Develop realistic physical/chemical specifications for finished formulations and Drug substances.
  • Work with Formulation to ensure that all products are formulated by strictly adhering to all process instructions to ensure consistent quality in each batch.
  • Develop measurements to ensure quality, accuracy, and efficiency in formulation by working with the formulation team.
  • Write SOPs, STMs, protocols, reports, and specifications.
  • Develop and implement Root Cause Analysis with QA assistance.
  • Work with supervisor in performing investigations for OOS & OOT.

Calibration, maintenance & troubleshooting of various equipment (HPLC, GC, KF Titrator, UV/Vis Spectrophotometer and Dissolution Apparatus)

Work Schedule: Full-time, 40 hours per week

Education: U.S. Master of Science in Chemistry
 
Experience: • 9 months experience in the job offered or as an Intern Chemist. Experience to include, 9 months experience in: performing description, identification, water content, assay and other tests on drug substances i.e. Active Pharmaceutical ingredient

Employer Name: Belcher Pharmaceuticals, LLC

Work Location(s):
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

----------------------------------------------------------------------------------------

Job Title: Director – Technical Operations

Job Duties:

  • Develop or implement policies, standards, or operating procedures for the technical work performed to ensure regulatory compliance such as USFDA, operations enhancement and increase productivity.
  • Determine technical goals within broad outlines provided by management and make detailed project plans, schedules and budget to accomplish these goals.
  • Hire and Supervise 10 employees: 3 Manufacturing Science & Technology; 1 Scientist (Process Development); 2 Quality Engineers; 1 x Chemist; and 1 Microbiologist; and Supervise 2 Principal Engineers Contractors
  • Develop client relationships and communicate with clients in the U.S. and across the globe, present technical/quality documents, establish specifications, and discuss project status for various sterile medicinal products to meet USFDA guidelines/specifications
  • Review project activities and prepare and review research, testing, or operational reports such as user requirement specifications, designs specification, functional specifications, technology transfer/process scale-ups documents, project plans, architectural plans and stability protocols/reports;
  • Confer with scientists, engineers, regulators, or others in the U.S. and across the globe to plan or review projects and provide technical assistance to transfer sterile medicinal products to manufacturing sites.
  • Design and coordinate successive phases of problem analysis, solution by performing risk assessments, failure mode and effective analysis, propose risk elimination/mitigation plans to accomplish highest quality of the medicinal products.
  • Advise and mentor manufacturing, quality and regulatory staff to establish and maintain facility, equipment/utilities to produce highest sterility assurance level in the manufacturing process.  
  • Perform and coordinate qualifications/validation to support manufacturing operations and ensure the performance of the equipment/process by conducting installation, operational and performance qualifications. This involves sterilization, cleaning and process.
  • Assess challenges and provide technical support to resolve the technical issues during manufacturing.
  • Detect technical manufacturing process problems and assist the contract research organization (CRO’s) for the resolution.
  • Provide input for investigations, commitments, and change controls assuring changes provide robust manufacturing process – ensures changes are value added.
  • Participate in cross-functional teams in the evaluation and implementation of novel manufacturing technology and processes in commercial processes that increase process robustness
  • Designing facilities, equipment, utilities to start up a new sterile medicinal products manufacturing facility
  • Process design to manufacture sterile medicines in a sustained release, sensitive to temperature, light and relative humidity.
  • Designing automatic/robotic fill machine to avoid human interventions and microbiological contamination.  

Work Schedule: Full-time, 40 hours per week

Education: Bachelor (or its foreign equivalent) in Pharmacy

Experience: 60 months of experience in the job offered or in the closely related job title of Validation & Aseptic Manufacturing Manager. Experience to include:

  • 24 months of experience in designing facilities, equipment, utilities to start up a new sterile medicinal products manufacturing facility;
  • 18 month of experience in process design to manufacture sterile medicines in a sustained release, sensitive to temperature, light and relative humidity;
  • 6 months of experience in designing automatic/robotic fill machine to avoid human interventions and microbiological contamination. 

Employer Name: Belcher Pharmaceuticals, LLC

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

12393 Belcher Road, Suite 450
Largo, FL 33773

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