Senior/Principal Process Development

STERLING PHARMA SOLUTIONS • Germantown, WI • 3h ago

JOB REQUIREMENTS: Summary of Role The Senior/Principal Process Development Scientist - HPAPIs is accountable for driving the development and optimization of robust, scalable synthetic processes for small molecule APIs - with a focus on highly potent active pharmaceutical ingredients (HPAPIs), payloads, linkers, payload-linker intermediates - from early development to technology transfer into manufacturing, in a fast paced CDMO environment. The incumbent will write and review technical documents including SOPs, training modules, technical transfer documents, specifications, and development reports to be sent to clients or used in regulatory filings and is responsible for ensuring complex technical information is well understood by team associates, management and clients. The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. The role requires expertise in the development of synthetic routes and scalable manufacturing processes for highly potent compounds, including antibody-drug conjugate (ADC) payloads, linker technologies, payload-linker intermediates, and related HPAPI molecules, with a strong focus on safety, containment, and successful transfer into cGMP manufacturing environments. Essential Functions As a part of a cross-functional development team, designs, plans, and executes process development and optimization for HPAPIs, payloads, linkers, payload-linker intermediates, and small molecule APIs, with ownership of synthetic strategy through to robust, scalable processes with minimal supervision. Performs process characterization through techniques such as Design of Experiments (DOE), and impurity fate/purge studies to understand and control critical process parameters, including those relevant to highly potent compounds and payload-linker syntheses. Oversees and supports lab to plant scale-up activities providing on site support as needed for critical operations and troubleshooting, including collaboration with analytical, quality, EHS, and manufacturing colleagues to ensure programs are delivered right first time while meeting containment and safe handling requirements for highly potent compounds. Executes synthesis activities from gram to multi-kilogram scale at up to 20 L scale, including routine maintenance and troubleshooting of laboratory equipment, containment systems, and engineering controls utilized for handling HPAPIs and payload-linker intermediates. Isolates and purifies products and intermediates by using standard laboratory techniques, including automated preparative chromatography systems. Designs multi-step synthetic processes from commercially available starting materials to target compounds, including ADC payloads, linker molecules, payload-linker intermediates, highly potent cytotoxic agents, and related pharmaceutical compounds. Performs routine analytical procedures to monitor reaction progress (i.e. TLC, GC, NMR, HPLC, LC-MS, KF), and interprets and communicates data effectively, including assessment of impurity profiles and product quality attributes. Prepares project documentation such as development reports, material specifications, containment assessments, and technology transfers of high technical complexity with minimal supervision. Serves as a chemistry technical lead and point of contact for client technical representatives during project meetings, technical reviews and site visits. Establishes and coordinates activities at contract chemical and analytical laboratories, as required. Ensures timely completion and compliance with cGMP, Safety, and all other relevant company training requirements. Provides technical leadership in the safe handling, process development, scale-up, an To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJnZW5lcmljLjY5NzY1Ljg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ *** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjY5NzY1Ljg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ

Similar Jobs

LEAD MEDICAL SUPPORT ASSISTANT

Veterans Affairs, Veterans Health Administration • Milwaukee, WI • 53min ago

Hospital & Medical

Summary This position is located at the Clement J. Zablocki VA Medical Center, Milwaukee,Wisconsin, in the Medical Information Systems Division, Benefits Management Program,Facility Access Section. Responsibilities VA Ca...

53min ago

Go to Apply

Medical Assistant Urgent Care

PROGRESSIVE COMMUNITY HEALTH CENTER • Milwaukee, WI • 53min ago

Hospital & Medical

JOB REQUIREMENTS: Come join our team! We are hiring! We are currently hiring a Medical Assistant in Milwaukee, WI. This is a full-time position that does require working weekends. Why Progressive Community Health Centers...

53min ago

Go to Apply

Medical Records Abstractor

PS COMPANIES • Milwaukee, WI • 56min ago

Hospital & Medical

JOB REQUIREMENTS: PS Companies is hiring a Medical Records Abstractor to support the Fetal and Infant Mortality Review (FIMR) process by reviewing and summarizing medical records. This role will start in mid-September Pa...

56min ago

Go to Apply

Engineer II, Facilities

BADGER METER INC • Milwaukee, WI • 1h ago

IT & Engineering

JOB REQUIREMENTS: Job Duties: Support facilities operations by troubleshooting varied infrastructure (HVAC, air, water, building construction, etc.), systems (CMMS, BAS, etc) and equipment in manufacturing and office ope...

1h ago

Go to Apply

Vice President Sales Marketing Motion

ABB, INC. • New Berlin, WI • 1h ago

Management & Administrative

JOB REQUIREMENTS: At ABB, we help industries run leaner and cleaner-and every person here makes that happen. You\'ll be empowered to lead, supported to grow, and proud of the impact we create together. Join us and help r...

1h ago

Go to Apply

Paid Media Lead

HARLEY-DAVIDSON MOTOR CO GROUP INC • Milwaukee, WI • 1h ago

JOB REQUIREMENTS: Auto req ID: 57483 Title:Paid Media Lead Job Function:Marketing Location:JUNEAU Workplace Category: Onsite Company:Harley-Davidson Motor Company Full or Part-Time:Full Time Shift:SHIFT1 In 1903, out of...

1h ago

Go to Apply

FP Systems Administrator

SILGAN CONTAINERS MFG CORP • Waukesha, WI • 1h ago

IT & Engineering

JOB REQUIREMENTS: FP&A Systems Administrator in Waukesha, WI Silgan Containers, North America\'s leading metal food packaging manufacturer, is hiring a full-time FP&A Systems Administrator to support our Oracle E...

1h ago

Go to Apply

Executive Assistant Investor Relations

ROCKWELL AUTOMATION INC. • Milwaukee, WI • 1h ago

JOB REQUIREMENTS: Milwaukee, Wisconsin, United States Rockwell Automation is a global technology leader focused on helping the world\'s manufacturers be more productive, sustainable, and agile. With more than 28,000 empl...

1h ago

Go to Apply

Business Development Advisor

MRA-THE MANAGEMENT ASSN INC • Waukesha, WI • 1h ago

Sales & Marketing

JOB REQUIREMENTS: Be the next FACE of MRA! Friendly. Accountable. Centered on Members. Engaged. That\'s the FACE Culture, and it\'s what we live and breathe every day at MRA. MRA (The Management Association) is seeking a...

1h ago

Go to Apply

Retail Finance Assistant

FABICK CAT • Milwaukee, WI • 1h ago

Retail & Hospitality

JOB REQUIREMENTS: Back Retail Finance Assistant #4026 Milwaukee, Wisconsin, United States Apply X Facebook LinkedIn Email Copy Shift 1st Job Description Company Overview: Fabick Cat is the authorized dealer of Caterpilla...

1h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)