Instagram
youtube
Facebook

Biologics Production - Executive

2-5 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Executive - Biologics Production

Job Summary:
The Executive in the Biologics Production Department will play a vital role in the manufacturing and production of biologic drugs at Promea. They will ensure the efficient and compliant production of biologics while adhering to quality standards, safety regulations, and production schedules.

Key Responsibilities:

  • Oversee and execute biologic drug manufacturing operations, including upstream and downstream processes, purification, and formulation.
  • Ensure compliance with current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs) throughout all production activities.
  • Prepare and review production documents, batch records, and production reports, ensuring accuracy and regulatory compliance.
  • Collaborate with cross-functional teams (process development, quality control, and engineering) to optimize production processes and troubleshoot technical issues.
  • Monitor production data, yield trends, and KPIs to identify areas for improvement and implement corrective actions.
  • Participate in technology transfer activities, including process scale-up, process validation, and equipment qualification.
  • Assist in investigations of deviations, out-of-specification results, and non-conformances, implementing corrective and preventive actions (CAPAs).
  • Ensure proper documentation and maintenance of equipment, production areas, and records in line with cGMP guidelines.
  • Contribute to continuous improvement initiatives, suggesting process enhancements, efficiency improvements, and cost-saving measures.
  • Stay updated on industry trends, regulatory requirements, and technological advancements, proposing and implementing relevant improvements.

Qualifications and Skills:

  • Bachelor’s or Master’s degree in Biotechnology, Biochemistry, or related field.
  • In-depth understanding of biologics production processes such as cell culture, fermentation, purification, and formulation.
  • Familiarity with cGMP guidelines and regulatory requirements in biologics manufacturing.
  • Experience with bioreactors, chromatography systems, filtration technologies, and other biologics production equipment.
  • Knowledge of process optimization, scale-up, and technology transfer in biologics manufacturing.
  • Strong analytical, problem-solving, and attention-to-detail skills for analyzing complex data sets.
  • Excellent organizational and time management abilities to manage multiple priorities and meet production schedules.
  • Effective communication and interpersonal skills for collaborating in cross-functional teams.
  • Proficiency in using manufacturing execution systems (MES) and production-related software.
  • Flexibility to work in shifts, including weekends and holidays, in a biologics production environment.