POSITION SUMMARYThe Process Science Group is a team of scientists and subject-matter experts specializing in the development of processes and procedures for the manufacture of drug substance and drug product. Within this group, this position serves as the technical lead for biologic drug product and device development spanning liquid and lyophilized formulations delivered via pre-filled syringe and autoinjector from early development through commercialization. The role requires close cross-functional collaboration with internal Process Science and Quality Control teams, as well as external development laboratories, CROs, and CDMOs.
PRIMARY RESPONSIBILITIES- Serves as technical lead for development and manufacturing of biologic drug products delivered via pre-filled syringe and autoinjector devices, spanning early development through commercialization for both liquid and lyophilized formulations.
- Provides technical direction and oversight to cross-functional internal teams, external partners, CROs, and CDMOs, ensuring development and GMP programs meet program objectives, regulatory expectations, quality standards, and timelines.
- Develops and executes drug product development strategies, including process development, technology transfer, scale-up, GMP manufacturing, process characterization, process performance qualification, validation, and commercial launch readiness.
- Authors and reviews technical documents supporting commercialization, including batch records, study protocols, technical reports, deviation investigations, change controls, and regulatory filings.
- Drives resolution of stalled or complex issues by escalating promptly to leadership and cross-functional teams; applies lessons learned to develop or update systems and processes that prevent recurrence.
- Maintains current knowledge of industry trends, compliance requirements, and best-in-class technologies through self-education, professional networking, and participation in industry organizations; applies this knowledge to PTx projects and solutions.
- Complies with all applicable regulations and requirements, including internal SOPs, GMP, health and safety standards (WISHA/OSHA), regulatory compliance, company policies, and employment laws.
- Completes all mandatory Quality and Compliance training within required timeframes.
KNOWLEDGE, SKILLS, ABILITIESRequired:- Strong knowledge and experience with commercial-phase drug product development, including formulation, process, container closure and delivery device.
- Knowledge of industry best practices and testing methodologies for biologics.
- Experience with technology transfer, GMP manufacturing and CDMO oversight.
- Working knowledge of cGMP and global regulatory expectations for biologic parenteral drug products, including liquid and lyophilized formulations.
- Understanding of biologics degradation mechanisms, formulation science and stabilization strategies.
- Maintains meticulous and accurate documentation of testing procedures, observations, and results.
- Strong written and oral communication skills with demonstrated ability to convey complex scientific and technical concepts through presentations and publications.
- Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
- Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues. Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
- Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
- Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
- Solid English language communication skills, both oral and written, are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask questions. Comfortable actively participating in cross-functional and executive level meetings.
- Proficiency with MS Office products, especially Word and Excel are essential; ability and willingness to quickly adopt other job-specific applications will be necessary.
Preferred:- Knowledge and application of USP, ICH, FDA, PMDA, and EMA guidance, with prior experience incorporating these standards into regulatory submissions, strongly preferred.
- Experience authoring and reviewing relevant CMC sections for regulatory amendments and briefing packages.
- Experience with analytical test methods for raw materials and biologic drug products.
- Experience managing commercial drug products through the full product lifecycle.
EXPERIENCE & EDUCATIONRequired:- PhD in Biochemistry, Bioengineering, Chemical Engineering, or a related scientific discipline, with 5+ years of progressively responsible, relevant experience; or an MS with 10+ years of progressively responsible, relevant experience; or a BS with 15+ years of progressively responsible, relevant industry experience.
Please note that we are unable to offer sponsorship for open positions at this time.PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for the Drug Product Development Lead is $157,000 - $170,000. Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.
In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual Hybrid or Remote workplace program for many roles. We also offer a highly competitive compensation and benefits package, including an annual discretionary cash bonus and a 401(k) matching program.Partners in the Seattle area can take advantage of a free ORCA pass, and we also provide tuition and continuing education assistance to support ongoing professional development. Recognition for outstanding contributions and achievements is a core part of our culture.
