Formulation and MSAT Lead
Formulation and MSAT Lead
Posted on :
31-10-2024
Employer Active
1 Vacancy
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Job Description
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fillfinish services. From IND applications through commercial scale production we provide formulation and compounding fillfinish and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team s expertise to create a process design for our clients products that best suits their needs.
The Experience
With operations spanning the globe and featuring a multicultural team BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At BioTechnique it s about more than just a job it s about your career and your future.
Your Role
The Formulation and MSAT Lead will play a critical role in supporting our fillfinish sterile injectable operations ensuring the successful development scaleup and transfer of robust formulations and manufacturing processes. Successful candidates will have a strong background in process engineering formulation development lyophilization principles lab testing and a thorough understanding of regulatory requirements within the pharmaceutical industry.
- Lead the formulation development of sterile injectable products including the design optimization and characterization of formulations.
- Oversee the scaleup and technology transfer of manufacturing processes to commercial production.
- Collaborate with crossfunctional teams to ensure seamless project execution.
- Develop and implement strategies for process optimization troubleshooting and continuous improvement.
- Ensure compliance with regulatory requirements and industry standards.
- Mentor and train junior scientists and technical staff.
- Prepare and review technical documents including protocols reports and regulatory submissions.
- Stay current with industry trends and advancements in formulation science and sterile manufacturing technologies.
- Participate in and support internal and regulatory authority facility audits and site inspections.
- Additional responsibilities as required to drive the successful development scaleup and transfer of robust formulations and manufacturing processes.
Requirements
- Bachelor s or advanced degree in Pharmaceutical Sciences Chemistry Chemical Engineering or a related field.
- 8 years of experience in pharmaceutical manufacturing industry supporting drug formulation and MSAT roles.
- Advanced knowledge of sterile injectable products and formulation.
- Must have experience with lyophilization processes/lyophilized products.
- Indepth knowledge of US and applicable global regulations including cGMP ICH guidelines and regulatory requirements for sterile products.
- Proven experience in leading technology transfer and scaleup activities.
- Direct experience with highpotency manufacturing and equipment; close understanding of containment requirements and controls.
- Excellent problemsolving skills with the ability to troubleshoot technical issues and implement effective solutions.
- Detailoriented with strong organizational skills capable of managing multiple projects simultaneously.
- Experience leading and managing teams fostering collaboration and providing mentorship to team members.
Benefits
Offering a full suite of benefits BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision BioTechnique pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more
- Financial Perks and Discounts
Equal Opportunity Employment Statement:
BioTechnique is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
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Bachelor s or advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field. 8+ years of experience in pharmaceutical manufacturing industry supporting drug formulation and MSAT roles. Advanced knowledge of sterile injectable products and formulation. Must have experience with lyophilization processes/lyophilized products. In-depth knowledge of US and applicable global regulations including cGMP, ICH guidelines, and regulatory requirements for sterile products. Proven experience in leading technology transfer and scale-up activities. Direct experience with high-potency manufacturing and equipment; close understanding of containment requirements and controls. Excellent problem-solving skills with the ability to troubleshoot technical issues and implement effective solutions. Detail-oriented with strong organizational skills, capable of managing multiple projects simultaneously. Experience leading and managing teams, fostering collaboration, and providing mentorship to team members.
Employment Type
Full Time
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