About the Role
Key Responsibilities:
Apply scientific principles to the manufacturing of intermediates and bulk drug substances, with an understanding of both chemistry and equipment interaction.
Lead and execute technical projects including laboratory experiments, data modeling, and production data analysis to improve yield, purity, process control, and productivity.
Provide technical input for key documentation such as validation protocols, change controls, regulatory submissions, technical reports, procedures, and deviation investigations.
Develop, monitor, and interpret process metrics to assess real-time variability and manufacturing capability.
Design and execute laboratory-scale experiments focused on process troubleshooting and optimization.
Evaluate and maintain process validation (including cleaning validation) and ensure accurate documentation of the control strategy.
Investigate production deviations using structured problem-solving tools.
Ensure instructions and documentation accurately reflect manufacturing processes and standards.
Requirements
Basic Qualifications:
Bachelor’s degree in a STEM discipline (Chemistry preferred) with a minimum of 3 years of experience in cGMP manufacturing; OR
Master’s degree with at least 1 year of experience in cGMP manufacturing.
Preferred Qualifications:
Demonstrated knowledge or hands-on experience in peptide synthesis.
Industry experience in API manufacturing, Technical Services/Manufacturing Sciences (TS/MS), Quality Control, Quality Assurance, or Product Development.
Strong understanding of cGMP standards and terminology.
Excellent analytical, verbal, and written communication skills.
Ability to work independently and collaboratively within cross-functional process teams.
Creative problem-solving skills and a proactive approach to process improvements.
Experience mentoring or guiding junior staff.
Flexible and adaptable to meet evolving business needs.
Additional Information:
Seniority Level: Associate
Experience Level: 2 to 5 years
Education Requirement: Bachelor’s degree or higher
Travel Requirement: Occasional
Security Clearance: Not required
Visa Sponsorship: Not available
About the Company
RepuCare, a certified Woman-Owned Business (WBE), is a leader in providing innovative workforce solutions. We have partnered with a global pharmaceutical client seeking a Manufacturing Scientist (LP1 Peptide Synthesis) to join their dynamic team. This is a hybrid role that combines in-office and remote work.