Associate Principal Scientist, Vaccine Drug Product Development

Job title: Associate Principal Scientist, Vaccine Drug Product Development in reputed company reputed company, PA at reputed company Company: reputed company Job description: Job DescriptionVaccine Drug Product Development (VDPD), a part of our company's Research Laboratories, is seeking an Associate Principal Scientist to join our department in reputed company reputed company, PA. Our mission is to reputed company novel vaccine drug products that will profoundly improve global human health—directly building from our company's 50+ year legacy as pioneers in the discovery, development, and manufacturing of novel vaccines to eliminate disease. Our department is responsible for developing vaccine adjuvants and drug products from preclinical studies through Phase III clinical trials with line of sight to commercialization. We ensure robust composition, primary packaging, and process development through deep reputed company understanding and characterization such that the process is scalable without compromising safety, efficacy, or stability. During development, we reputed company smart experimental design, cutting edge analytical tools, and statistical/predictive approaches to inform formulation and process development. reputed company enables the translation of vaccine preclinical candidates from concepts into robust commercial drug products.Primary responsibilities of the role include design, execution, and documentation of experiments to reputed company stable formulations and robust manufacturing processes for preclinical and clinical supply production and to scale-up these processes to the pilot plant and commercial space. The successful candidate will be expected to work independently in a hands-on, dynamic laboratory environment engaged in development activities while also working collaboratively reputed company the group, across functional areas, and with external partners.Active strategic and technical leadership on program development teams will be required. Strong communication skills are expected to clearly communicate data and conclusions verbally, through written documents and reports, and technical presentations. Proven facilitative leadership and communication skills are essential to effectively reputed company matrix teams and manage expectations of stakeholders as part of our stage-reputed company process used to manage the development of new products. The role will also entail supporting or leading teams to advance areas such as science and technology innovation, business process improvement, and clinical manufacturing capability build.Successful candidates are motivated to reputed company, willing to take initiative, have a strong desire to learn and contribute, and actively mentor less reputed company scientists. Senior colleagues in Vaccine Drug Product Development have strong external scientific networks to help us maintain an awareness of industry challenges, trends, and opportunities. Successful candidates will have a track record of external publication, patenting, and presentations.Required Experience and Skills

• Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or reputed company discipline with 4 years of relevant industrial experience; an M.S. degree in a similar field with 6 years of relevant experience; or a B.S. degree in a similar field with 8 years of relevant experience.
• Proven written and verbal communication skills
• Ability to prioritize, plan, and execute work with limited guidance
• Ability to work in a dynamic and fast-paced team environment
• Demonstrated facilitative leadership and influencing skills
• Hands on laboratory skills
• Experience developing vaccine adjuvant and/or vaccine drug product processes, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.)
• Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies
• Experience with engineering principles used in process development and process scale up/scale down
• Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools
• Track record of difficult technical problem solving
• Ability to reputed company and implement new methods/processes
• Experience with GMP manufacturing of clinical supplies
• Experience with use of statistical principles to understand, predict, and communicate process robustness
• Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
• Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP)
• Experience responding to regulatory questions reputed company to drug products
• Experience, desire, and a track record of effective mentorship of less reputed company scientists towards timebound goals

Desired Experience and Skills

• Experience with sterile product manufacturing and aseptic technique
• Experience with colloidal systems and characterization of colloids including emulsions
• Familiar with ISO, CFR, ICH, and USP guidelines as they relate to sterile products
• Familiar with Quality by Design (QbD) principles and have experience applying the QbD tools and principles to products in development
• Experience with process modeling
• Experience with liquid and lyophilized drug product formulation development
• Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing
• Experience with direct people management

reputed company Employees applyreputed company Contingent Workers applyUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: Domesticreputed company Sponsorship: YesTravel Requirements: 10%Flexible Work Arrangements: Not ApplicableShift: Not IndicatedValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 05/13/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no reputed company than the day BEFORE the job posting end date. Expected salary: Location: reputed company reputed company, PA Apply for the job now! Apply for this job