Associate Engineer Drug Product Development Job at Piper Companies (Branchburg)

Associate Director, Drug Product Manufacturing and Development (Oral)

The Associate Director, Drug Product will support drug product activities with e...

Location

United States , San Diego

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in the pharmaceutical industry with a proven track record of technical expertise in unit operations common to solid oral dosage form (e.g., dry granulation, compression and film-coating)
Extensive experience with management and oversight of activities at CDMO’s
Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
Strong working knowledge of Excel, Word, PowerPoint
Experience drafting CMC documents for regulatory filings
Experience using quality systems such as Veeva to author and approve documents
Excellent verbal, written and interpersonal skills
Innovative team-player capable of working cross-functionally to achieve program goals
Ability to travel up to 20% (domestic and international)
Bachelors Degree in Engineering, Pharmaceutical Sciences, Life Sciences or closely related field

Job Responsibility

Contribute to the selection, engagement, and management of CDMO’s, including assessment of capabilities, drafting requests for proposals, and providing recommendations based on selection criteria
Coordinate technology transfer, formulation and process development, optimization, scale-up and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
Review master batch records and executed batch records to ensure product quality
Manage cGMP change controls and manufacturing deviations as necessary, working closely with Kailera’s quality group
Lead initiatives to enhance manufacturing efficiency, reduce costs and improve product quality through experimental design with a focus on commercial preparedness
Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD and NDA)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...

Location

United States , Thousand Oaks

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of Manufacturing support experience
Bachelor’s degree and 4 years of Manufacturing support experience
Associate’s degree and 8 years of Manufacturing support experience
High school diploma / GED and 10 years of Manufacturing support experience

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire
Support timely investigation and resolution of manufacturing deviations

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...

Location

United States , Thousand Oaks

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Manufacturing support experience
Associate’s + 2 years Manufacturing support experience
Bachelor’s + 6 months Manufacturing support experience
Master's
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
Support timely investigation and resolution of manufacturing deviations

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior Engineer- Process Development/NPI

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , New Albany

Salary:

123098.00 - 149145.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of Process Development, Engineering, or NPI experience
Bachelor’s degree and 4 years of Process Development, Engineering, or NPI experience
Associate’s degree and 8 years of Process Development, Engineering, or NPI experience
High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience

Job Responsibility

Serve as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio
Lead multi-functional NPI teams
Lead the NPI’s for necessary process, facility, equipment, materials, and training modifications
Development of project execution plans
Ensuring process requirements are effectively transferred into manufacturing
Coordination/execution of NPI activities
Function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management
Engage with network partners to develop process and technology strategies
Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes
Support generation, revision, review, execution, and approval of relevant technical documents

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime