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Sr. Formulation Scientist
Posté 03 avr. 2023
Indianapolis, Indiana - United States
Demander un identifiant 262815
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Responsible for complex formulation and process development activities associated with sterile injectable and lyophilized drug products. Efforts will focus primarily on liposomes and lipid-based formulations. Executes assigned tasks within the constraints of timelines, under minimal supervision by senior scientific staff.
This role will be supporting the development of innovative drug delivery approaches, and feedback/observations from the analytical work will be sought to guide future work. A person with an innate scientific curiosity and keen observation skills will have the opportunity to impact future medicine development.
This position will provide key development, engineering and validation support and project coordination primarily to the manufacturing process side of manufacturing plant operations. Additionally, technical support for process and product investigations will be required.
Major Position Activities & Responsibilities:
- Provide strategic and technical leadership in the areas of formulation and drug delivery.
- Provide in-depth technical expertise and adapt formulation solutions to complex products under development.
- Transition products from laboratory bench scale through small scale cGMP clinical manufacture to fully validated commercial scale production, following Quality by Design (QbD).
- Partner with the analytical technical services group and manufacturing personnel to develop robust manufacturing processes suitable for routine production.
- Innovate or assess formulation methodologies for complex or unstable bio products i.e. liposomes, RNA, peptides, proteins, fusion proteins and drug conjugates
- Lead other laboratory personnel in the design, execution and interpretation of experiments to drive the definition and optimization of formulations
- Seek opportunities to collaborate with academic and industry partners and organizations as appropriate in order to develop novel formulation strategies for complex drug products under development.
- Stay current with recent advances and trends in drug delivery technology and regulatory policies.
- Coaching, training and mentoring junior engineers/scientists
- Conduct laboratory operations in a safe manner. Maintain compliance with the Chemical Hygiene Plan. Exhibit safety awareness and safe work practices.
- Follow responsible actions regarding chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels, cGMP as well as appropriate SOP’s.
- Present quality written documentation, notebooks, methods, validation reports, data reports and summaries.
- Report and treat data with a high level of integrity and ethics
- Develop efficient, appropriate formulation procedures for assigned compounds and Standard Operating Procedures (SOPs) for new equipment/processes.
- Support Regulatory Affairs for IND/NDA/ANDA/BLA filings.
- Discuss routinely with supervisor, project manager and peers the status of the assigned programs and potential problems.
- Communicate effectively in verbal and written form on research results, issues, and plans.
- Provide technical support for the manufacturing processes, including process investigations, process changes, and technical transfer and scale up of new product introductions.
- Provide project and process engineering support for technical projects. Associated tasks include equipment specification and procurement, process development, drawing development, protocol development and execution.
- The individual will be required to lead and supervise a project-defined team comprised of personnel from multiple departments as well as outside contractors. Responsible for small scale project budgets up to $250K in value. Responsible for support of all types of facility projects, including pre-clinical development, clinical and commercial product tech transfer. Project reporting is a dotted line structure with respect to specific project responsibilities only. Responsible for no direct staff.
Who You Are:
- Hands-on experience and technical leadership in pharmaceutical formulation concepts and process development, specifically with novel drug product delivery projects, liposomes and nanoparticles and lyophilized drug products
- MS degree in one of the following disciplines (Chemical/Biochemical Engineering, Pharmaceutical Sciences, Polymer Science, Materials Science, or Chemistry/Biochemistry), with 5 years of relevant experience (academic/industrial) with pharmaceutical process and formulation development. A PhD is a plus. BS in the above disciplines would also be considered with appropriate work experience.
- Proficiency in wet chemistry techniques. Proficiency in HPLC, particle sizer, lyophilization equipment, autoclave is preferred.
- Proficiency in the use of Microsoft Office products (Word, Excel, Visio, etc.)
- Minimum 1 year of experience with HPLC in a regulated lab is required. Experience with Empower software is preferred.
- Ability to independently perform root cause analysis for investigations
- Proven problem solving and troubleshooting abilities
- Time management skills and ability to manage multiple projects, duties and assignments concurrently
- Effective written and oral communication skills
- Ability to work in a collaborative work environment with a team
- Experience with statistical designs of experiments (DOE) methodology.
- Demonstrated understanding of USP, FDA, EU, and ICH requirements for drug products and product development.
- Strong hands-on skills are required
- Employee must be self-motivated, highly organized, and conscientious.
- Employee must have sufficient mobility to work in a process environment.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html