Careers


Sigmapharm Laboratories LLC, is a rapidly growing, fully integrated pharmaceutical company, we offer challenging careers and opportunities for professional growth in research and development, product development, manufacturing, manufacturing technology, marketing, sales, legal, regulatory, IT, and finance. We also offer employee benefits in an environment that is challenging, stimulating, and rewarding.

 

Sigmapharm is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Sigmapharm also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the U.S. for Sigmapharm.

 

Manager, Analytical R&D

Research, analyze, and design experiments including dissolution and drug release procedures for cGMP compliance; Manage and oversee resources and research activities to complete method development, enhancement, validation, and documentation for ANDA and pharmaceutical product launches using HPLC, GC, ICP-MS, LC-MS, XRD; Perform critical review of Drug Master File, Technical Packages, Raw Material Specification, and Certificate of Analysis for conformance to USP for ANDA/NDA submission; Write and execute EQ protocols and set up qualification program for new instruments; Perform Stability excipients compatibility studies; Review notebooks and raw data for; Oversee maintenance of laboratory in compliance with SOPs, cGMPs, FDA, ICH and OSHA regulations. Supervise 6 chemists.

 

Must have a Master’s Degree in Chemistry or Analytical Chemistry plus 2 yrs of experience in job offered, requires skills and knowledge in HPLC, GC, method development/validation, FDA/ICH, Stability excipients compatibility studies, ICP-MS, LC-MS, XRD.

 

Job location: Bensalem, PA. Submit résumé referencing Job Code SRP004 to HR, SigmaPharm Laboratories, LLC, 3375 Progress Drive, Bensalem, PA 19020.

 

Regulatory Affairs Specialist

Coordinate and document internal regulatory processes including internal audits, inspections, license renewals, and registrations; Coordinate, prepare, and review regulatory submissions for domestic and international drug submissions and approvals; Maintain current knowledge base of existing and emerging regulations, standards, and guidance documents for international pharmaceutical markets; Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes; Prepare and direct the preparation of information and responses requested by regulatory agencies in the international and domestic markets.

 

Must have a Bachelor’s Degree in Regulatory Affairs or Law plus 2 yrs of experience in job offered or as Lawyer with expirence in regulatory affairs. Require skills and knowledge in pharmaceutical regulatory submission.

 

Job location: Bensalem, PA. Submit résumé referencing job code ALA001 to HR, Sigmapharm Laboratories, 3375 Progress Dr, Bensalem, PA 19020.

 

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