Associate Principal Scientist, Sterile Product Development

Job Description

Job Description:

The Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections implants inhaled ocular) for small intermediate and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition primary packaging/device and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability safety efficacy and delivery. During development we leverage smart experimental design cutting edge analytical tools and predictive approaches to inform molecule formulation and process summary our team enables the translation of preclinical candidates into non-oral drug products.

We are seeking a highly motivated candidate for the position of Associate Principal Scientist (R4) focused on developing parenteral drug products across a range of modalities (small molecule peptides proteins antibody-drug conjugates and biologics). The successful candidate must be able to collaborate in a fast-paced integrated multidisciplinary team environment.

Primary duties:

• Lead/ contribute towards the new innovative approaches for biologics sterile product development through the generation of experimental designs execution of experimental plans and data analysis

• Support both early and late-stage development candidates including screening and development of robust drug product composition scalable process primary packaging compatibility characterization for processing and administration and supporting regulatory filings.

• Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.

• Active strategic and technical leadership on program development teams interfacing with key stakeholders and collaborating across functions to drive defined milestones will be required.

• Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals.

• Be willing to take initiative motivated to excel have a strong technical background have excellent communication and interpersonal skills ability to multi-task mentor scientists and a strong desire to learn and contribute.

• Leads project activities at external manufacturing sites including tech transfers

• Enhance our Companys professional image and competitive advantage through patents presentations publications and professional activities and advance areas such as science and technology development technical and business strategic improvements business process innovations

• Maintain awareness of relevant new and current technologies capabilities and effectively share this knowledge with others

Education Minimum Requirement:

• Ph.D. in Chemical Engineering Biomedical Engineering Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry experience.

• B.S. or M.S. degree in Engineering Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.

Required Experience and Skills:

• Experienced in biologics process development and characterization particularly for late stage programs

• Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process

• Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas

• Has broad knowledge of formulation science and in depth-knowledge in multiple areas including core understanding of the drug development process

• Track record of working effectively with team-members of diverse skill sets and backgrounds

• Strong verbal and written communication skills

• The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent.

Preferred Experience and Skills:

• Deep understanding of one or more of the following: surface science colloid science particle engineering and/or high concentration formulations

• Prior experience leading development projects at an enterprise level

• Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor

• Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology

• Demonstrated ability to identify fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.

• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.

• Prior experience with process scale up modeling regulatory filings and/or driving key capability evaluation/ build would be highly preferred.

Required Skills:

Preferred Skills:

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Effective 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 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.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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