Process Engineer responsible for developing PV protocols, coordinating execution of PV protocols, and supporting documentation and resolution of deviations in a GMP-regulated environment.
Compensation
National (US) Range
$84,885—$127,144 USD
Responsibilities
Meet with stakeholders and SMEs to gather input and develop PV protocols in preparation for and throughout Process Performance Qualification (PPQ)
Coordinate execution of PV protocols, including sampling plans, testing, data tracking, and data collection
Partner with internal functional groups (such as Manufacturing, Quality, Quality Control, and MSAT) and external CDMOs and contract laboratories to keep sampling, testing, and reporting on schedule
Provide day-to-day oversight of vendor and CDMO PV activities, tracking milestones, deliverables, and open items and escalating risks to SMEs and project leadership
Track and compile PV data, reviewing it for completeness and accuracy and flagging trends or unexpected results to SMEs
Requirements
Bachelor’s degree in Engineering (Chemical, Biomedical, Biochemical, or similar), Life Sciences, or a related technical field
Lead complex Global CMC programs and Operations Global CMC teams, while also providing leadership for the GTO Biologics Technology Transfer organization, shaping its ways of working, organizational design, capabilities, governance, and talent to enable successful and sustainable technology transfer across the global network.
Locations (2)
Södertälje, Stockholm County, Sweden
Gaithersburg, Maryland, United States
Responsibilities
Lead Operations Global CMC teams for complex biologics and other advanced modalities, with end-to-end accountability from development and PPQ through commercialization and lifecycle management
Define and drive integrated CMC strategies that ensure operational readiness, regulatory alignment and reliable market supply, managing risk and enabling timely decisions
Lead and develop the GTO Biologics Technology Transfer organization, including operating model, governance, capabilities and talent strategy
Implement business processes for right-first-time, rapid and robust transfers, driving standardization, clear roles, governance, risk management and continuous improvement
Senior Director, CMC Product Lead and Biologics Technology Transfer – Global Operations
Senior Manager overseeing external manufacturing operations, coordinating schedules, technology transfer, and partner performance for biologic drug substance and product manufacturing.
Compensation
The salary range for this position ranges from $150,000 - $160,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months.
Responsibilities
Coordinate day-to-day manufacturing activities against approved production schedules
Lead routine operating meetings and contribute to business reviews
Monitor partner performance and develop mitigation plans
Provide on-site support during selected manufacturing campaigns
Coordinate operational readiness for technology transfers and validation
Requirements
Bachelor's degree in engineering, biotechnology, biology, biochemistry, pharmaceutical sciences, life sciences, or a related discipline
Nice to have: Master's degree
Nice to have: MBA
Nice to have: direct experience with CMO/CDMO relationships
Nice to have: clinical and/or commercial biologics
Lead and manage quality control for biologics programs, develop strategies, oversee testing, and guide regulatory activities.
Compensation
The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Responsibilities
Serve as the QC Lead and primary Quality Control point of contact for assigned biologics programs
Develop and maintain phase-appropriate, end-to-end QC strategies
Own or provide senior oversight of specifications and analytical methods
Provide QC oversight for testing performed at internal laboratories, CMOs/CDMOs, and contract testing laboratories
Provide scientific and quality guidance for deviations and regulatory content
Requirements
Ph.D. with 2+ years experience
M.S. with 8+ years experience
B.S. with 10+ years industrial experience
Nice to have: MS, MD, PharmD, or PhD
Nice to have: extensive progressive experience in biopharmaceutical or pharmaceutical Quality Control
Lead Quality Control for biologics programs, overseeing QC strategy, regulatory compliance, and cross-functional teams.
Compensation
The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Responsibilities
Serve as QC Lead and primary QC point of contact for assigned biologics programs
Develop and maintain phase-appropriate QC strategies
Provide QC oversight for testing performed at internal laboratories, CMOs/CDMOs, and contract testing laboratories
Provide scientific and quality guidance for deviations and regulatory content
Lead cross-program initiatives for QC governance and harmonization
Senior-technical leader for the end-to-end Cell Therapy manufacturing across a global network of AstraZeneca’s manufacturing sites.
Compensation
The annual base salary for this position ranges from $216,996.00 - 325,494.00.
Responsibilities
Define and execute the Global MSAT function strategy aligned with Cell Therapy Technical Operations
Build, mentor, and develop a high-performing Global MSAT team
Serve as a core member of the CMC lifecycle management team
Develop technical standards and templates for the process validation and market approval workflow
Represent Global MSAT in the technology transfer and process characterization teams
Requirements
B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline
Lead and manage complex customer programs for oral solid dosage pharmaceutical products, overseeing the Italy PM team and driving project delivery from development to commercial launch.
Compensation
Gross Annual Salary range (RAL): €65k to €85k
Responsibilities
Directly supervise, coach and develop a small team of PMs; establish objectives and individual development plans; hold regular one-to-ones; provide timely feedback; conduct performance evaluations; support recruitment and onboarding; manage workload, coverage and capability gaps.
Personally lead selected high-complexity customer projects from development and technical transfer through scale-up, process validation/PPQ and commercial launch; establish scope, deliverables, integrated schedules, dependencies, critical paths and decision logs; drive timely execution and issue resolution.
Integrate plans for API/excipient readiness, equipment and production slots, granulation, blending, compression, encapsulation, coating, packaging, QC testing, method transfer/validation, stability and batch release; coordinate interfaces when manufacturing and packaging/testing occur at different sites.
Partner with Pharmaceutical Development, QA, QC, Industrialization and Manufacturing to track readiness, deviations, change controls, validation protocols/reports and batch disposition; Escalate GMP risks promptly while respecting Quality Unit independence and technical ownership.
Monitor project budgets, forecast milestones and revenue timing; identify scope creep and change-order opportunities; work with the Proposal team to request and approve change order opportunities.
Associate Director, Tech Transfer & Lifecycle Lead 80-100%
Take ownership of critical customer programs and play a pivotal role in bringing innovative products to market, leading technology transfers, commercial launches and lifecycle management activities within a state-of-the-art Drug Product fill & finish manufacturing facilities.
Responsibilities
Lead high-value and high-complexity Drug Product technology transfer and product lifecycle programs, driving the end-to-end journey from clinical development through process validation (PPQ), regulatory submission, commercialization, CPV/OPV and lifecycle management.
Act as the senior technical authority for complex customer programs, defining commercialization and validation strategies, providing technical governance, and serving as the escalation point for critical manufacturing, process and compliance challenges.
Lead the transfer, scale-up and implementation of Drug Product manufacturing processes into GMP operations, ensuring manufacturing readiness, successful commercial launch and sustainable routine production performance.
Develop and oversee Stage 1, Stage 2 and Stage 3 Process Validation strategies, including risk assessments, PPQ execution, statistical evaluations, trend analysis, process monitoring and post-approval change assessments.
Partner closely with customers and cross-functional stakeholders across Manufacturing, MSAT, QA, QC, Regulatory Affairs and Supply Chain to deliver program milestones, support regulatory submissions, and ensure inspection readiness for PAI and GMP audits.
Skills
Drive network technology transfer deliverables in line with Operations priorities and commercialization timelines, and represent the network in Operations-wide initiatives
Requirements
Degree in a relevant scientific or engineering discipline
Bachelor’s degree or higher in pharmacy, chemistry, pharmaceutical sciences, chemical engineering, engineering, or related scientific/technical discipline
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