Senior Chemist (Pharmaceutical)

Chemistry & Physics (Science & Technology)

Full time

Responsibilities:

1. Primary commitment to patient safety and product quality.
2. Understand and comply with all regulations governing the quality systems.
3. Delivery of key quality and performance objectives. Maintenance of laboratory scorecards and trackers.
4. Ensure compliance with mandatory training requirements and maintain up-to-date training records compliant with cGMP.
5. Responsibilities may include test method development and validation, raw material, in-process, finished product, and stability testing.
6. Complete documentation associated with testing/method development & validation/equipment qualification in a timely manner.
7. Ensure all analytical testing is carried out as defined in the Quality System.
8. Perform equipment calibration and qualification as required.
9. Review all laboratory quality systems to ensure compliance with cGMP.
10. Participate in regulatory, internal (auditor/auditee), and vendor audit programs as required.
11. Provide training (induction/on the job/procedures and updates), technical guidance/troubleshooting to laboratory staff including review of associated training records.
12. Review and approve laboratory results and documentation, including trending and charting of data.
13. Perform and assist with additional duties as directed by the QC supervisor.
14. Proficient in the use of various software applications utilized in the laboratory. Develop, configure, and validate software in accordance with Boston Scientific and industry standards as required.
15. Create, review, and approve change requests as necessary. Approve CRs as laboratory trainer where required.
16. Create purchase requisitions for laboratory equipment and consumables.
17. Manage laboratory spending and approve vendor invoices.
18. Manage laboratory inventory and supplies and order as necessary.
19. Manage laboratory training process and maintain training status.
20. Provide analytical support to process validations.
21. Participate in LBP/VIP and continuous project teams as required.

Requirements:

• Candidate must possess at least a Bachelor's Degree in Chemistry, Engineering (Chemical), Biotechnology, Engineering (Bioengineering/Biomedical), or equivalent.
• Required skills: Strong chemical analytical skills, laboratory controls skills for testing and releasing of chemicals, problem-solving and continuous improvement skills, good interpersonal and stakeholder management skills.
• Required language(s): English
• At least 8 years of working experience in the related field is required for this position.
• Experience with LIMS (Laboratory Information Management System) is preferable.

Company Overview:

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare.

Boston Scientific by the numbers:

• 45K employees worldwide
• 33M patients treated each year
• 16,000+ products that change lives
• $12.682 billion sales in 2022
• 130 countries with commercial representation

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia, Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.