Business Services & Consulting • all cities, NJ 32
Works within a highly cross-functional team in biologics process development to advance products from early- to late-stage development. Supports downstream purification/PEGylation/formulation with a focus on late-stage development.
Designs, executes, and optimizes downstream purification unit operations, including Refold, Clarification/Depth Filtration, IEX, HIC chromatography, and TFF/crossflow, to deliver scalable, high-yield, high-purity processes that meet target CQAs. Process Transfer, Validation, and Technical Support Provides on-site and remote support for manufacturing processes, addressing technical issues that arise during production. Reviews and approves GMP documentation, supports investigations by applying rigorous scientific principles and data analysis to solve complex process challenges. Leads process changes and new process transfers from development to manufacturing; acts as a liaison between PD and Manufacturing.
Serves as the DSP representative on CMC teams; integrates with Upstream, Analytical Development, Formulation, Quality, and Regulatory to align development plans, timelines, and deliverables. Prepares and delivers technical presentations and updates to project leadership, governance, and external partners/CMOs.
Demonstrated expertise in protein chromatography (IEX, HIC), depth filtration, and TFF/crossflow from lab to pilot scale.Conjugation expertise is a plus.Experience operating ÄKTA systems and control software (e.g., UNICORN), including proficiency in column packing/unpacking and membrane operations.Familiarity with cGMP expectations for clinical manufacturing and authoring and reviewing cGMP-aligned documentation.Experience collaborating with manufacturing, supporting engineering and clinical runs, and executing process transfers.Strong cross-functional communication and stakeholder management in a matrixed environment, with the ability to present complex data clearly to technical and non-technical audiences.
Excellent oral and written communication skills.Strong attention to data integrity and safety; results-oriented, organized, and thorough.
A bachelor's degree in an engineering discipline is required. Equivalent experience may be considered.
8 years of industry experience is required, including 5 years in GMP research, development, operations, manufacturing, pharmaceuticals, or another regulated environment. Postdoctoral work may be considered as experience.
May require up to 50% domestic and international travel to contract manufacturing sites or business partners.
Nektar currently anticipates the base salary for the Senior Drug Product Process Engineer to range from $170,000 to $190,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience.This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion.
The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
Works within a highly cross-functional team in biologics process development to advance products from early- to late-stage development. Supports downstream purification/PEGylation/formulation with a focus on late-stage development.
Designs, executes, and optimizes downstream purification unit operations, including Refold, Clarification/Depth Filtration, IEX, HIC chromatography, and TFF/crossflow, to deliver scalable, high-yield, high-purity processes that meet target CQAs. Process Transfer, Validation, and Technical Support Provides on-site and remote support for manufacturing processes, addressing technical issues that arise during production. Reviews and approves GMP documentation, supports investigations by applying rigorous scientific principles and data analysis to solve complex process challenges. Leads process changes and new process transfers from development to manufacturing; acts as a liaison between PD and Manufacturing.
Serves as the DSP representative on CMC teams; integrates with Upstream, Analytical Development, Formulation, Quality, and Regulatory to align development plans, timelines, and deliverables. Prepares and delivers technical presentations and updates to project leadership, governance, and external partners/CMOs.
Demonstrated expertise in protein chromatography (IEX, HIC), depth filtration, and TFF/crossflow from lab to pilot scale.Conjugation expertise is a plus.Experience operating ÄKTA systems and control software (e.g., UNICORN), including proficiency in column packing/unpacking and membrane operations.Familiarity with cGMP expectations for clinical manufacturing and authoring and reviewing cGMP-aligned documentation.Experience collaborating with manufacturing, supporting engineering and clinical runs, and executing process transfers.Strong cross-functional communication and stakeholder management in a matrixed environment, with the ability to present complex data clearly to technical and non-technical audiences.
Excellent oral and written communication skills.Strong attention to data integrity and safety; results-oriented, organized, and thorough.
A bachelor's degree in an engineering discipline is required. Equivalent experience may be considered.
8 years of industry experience is required, including 5 years in GMP research, development, operations, manufacturing, pharmaceuticals, or another regulated environment. Postdoctoral work may be considered as experience.
May require up to 50% domestic and international travel to contract manufacturing sites or business partners.
Nektar currently anticipates the base salary for the Senior Drug Product Process Engineer to range from $170,000 to $190,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience.This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion.
The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
