About the Job
Position: Pharmaceutical Development Team Leader - Solid Pharmaceutical Forms
Location: Azuqueca de Henares
Experience: At least 5 years in similar functions.
Company Overview: INSUD PHARMA operates throughout the pharmaceutical value chain, providing expertise and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceuticals. INSUD PHARMA's activity is organized in three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries.
What Are We Looking For?
We are incorporating a new INSUDER as a Pharmaceutical Development Team Leader to join the RD team at our plant in Azuqueca de Henares.
The Challenge:
1. Plan, organize, and coordinate the activities of pharmaceutical and analytical development to ensure the proper progress of the projects.
2. Assess and monitor activities of formulation scientists, analyzing and evaluating the results to develop robust formulations and processes.
3. Design, direct and/or follow pre-formulation (compatibility studies), formulation development, process development, process optimization/scale-up on assigned projects.
4. Serve as a technical expert to select suitable formulation strategy and process development activities.
5. Provide troubleshooting and optimization of formulations, process performance, and technical performance in cooperation with the production department.
6. Perform literature searches, extract relevant information from patents and scientific publications.
7. Write and/or review protocols, reports, master batch records, technical transfer documents, and other key documents as per ICH guidelines and regulatory requirements.
8. Prepare product development reports, write and review quality overall summary and other documents to support CMC regulatory submissions for filing and answering deficiency letters.
9. Prepare and approve scientific documentation for quality and regulatory affairs to support projects assigned to RD and to meet the standard approval flow established by the quality system.
10. Prepare the annual budget and needs assessment for both equipment and human resources, and actively participate in the recruitment and development of the team.
11. Analyze the status of patents that affect products under development and the results obtained in the bioequivalence studies.
12. Prepare summary reports and presentations for review by management.
13. Collaborate and interact closely with the analytical development scientists and the manufacturing department.
14. Supervise, motivate, coach, and develop the team.
15. Ensure good relationships and collaboration with all other teams involved in the development, QA, Patents, Medical, Regulatory Affairs, etc.
16. Ensure good relationships and efficient follow-up and tracking of development activities outsourced to third-party organizations.
17. Advise and report on ways forward for development, deviations, and modifications of pharmaceutical formulations, according to SOP's, ICH, EMEA, FDA guidelines, Annual Planning Projects, and annual budgets.
Qualifications:
Education: MSc Degree in Pharmacy, Chemistry, or related scientific degree in Pharmaceutical Sciences. PhD in Pharmaceutics is a plus.
Languages: Fluent in English, basic knowledge of Spanish, knowledge of other languages will be an asset.
Experience: 5 years of experience with formulation projects in the pharmaceutical sector. Clinical and regulatory affairs experience desirable. Proven leadership skills.
Specific Knowledge: Knowledge of GMP regulations and FDA requirements.
Travels: Open to travel.
Personal Skills: Impact and influence, good communication and project management skills, team leadership.
Our Benefits:
1. Flexible entry time from Monday to Friday (full-time 40 hours).
2. Indefinite term contract.
3. Attractive salary package.
4. Life and accident insurance.
5. Company canteen (free of charge).
6. Co-payment on voluntary health insurance.
7. Benefits and Savings Club.
8. Development plans, internal mobility policy.
What Will the Recruitment Process Be Like?
1. Watch out for the phone and email; we will contact you via one of these methods.
2. Be well prepared for a face-to-face/virtual interview depending on availability and agreement.
3. Wait for the result; we aim to keep you informed about the status of the process.
Commitment to Equal Opportunities: The InsudPharma group is committed to equal opportunities and treatment between men and women, and does not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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