Process Research Director jobs in New Jersey
Process Research Director manages the design and implementation of manufacturing processes. Researches and develops methods to increase productivity, decrease costs, maintain quality and consistency in current products, and discover new products. Being a Process Research Director requires a bachelor's degree. Typically reports to a top management. The Process Research Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Process Research Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Process Research Director jobs
Research Fellow, Chemical Process Development
- PTC Therapeutics, Inc.
-
Bridgewater, NJ
FULL_TIME
-
Job Description Summary
The Research Fellow, Chemical Process Development coordinates activities in Active Pharmaceutical Ingredients (API) process scale-up, process improvement and process optimization studies. The incumbent supports the transfer of technology to commercial manufacturing partners, monitors the manufacture of API and monitors stability data generated by Contract Manufacturing Organizations (CMOs).
The incumbent works cross-functionally with internal departments and external partners on Process Chemistry related issues.
The Research Fellow, Process Chemistry supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description
ESSENTIAL FUNCTIONS
Primary Duties/responsibilities- Designs, evaluates, and optimizes scale-up routes of small molecule candidates for pre-clinical testing.
- Assists in the identification, development, and implementation of policies, procedures and standards which impact the API manufacturing department, while working to ensure compliance with applicable regulatory requirements.
- Provides production process troubleshooting support to CDMOs including travel to external manufacturing facilities to monitor API production.
- Works with CDMOs in optimizing manufacturing processes in a stage appropriate manner.
- Compiles and maintains accurate records of laboratory experiments and data.
- Acts as API Subject Matter Expert on project teams.
- Partners with Regulatory in drafting Drug Substance sections in regulatory submissions.
- Works closely with Analytical Development in setting specifications for starting materials, intermediates and final products and supporting analytical validation.
- Interacts closely with Formulation Development to ensure API requirements and needs are met.
- Collaborates with Quality Assurance in adhering to GMP manufacturing quality standards.
- Supports Regulatory in responding to queries from regulatory agencies.
- Performs other tasks and assignments as needed and specified by management.
- Minimum level of education and years of relevant work experience.
- PhD in Organic Chemistry and a minimum of 7 years of experience in process chemistry in a pharmaceutical, biotechnology, CMO or related environment OR equivalent experience and/or education.
- Special knowledge or skills needed and/or licenses or certificates required.
- Hands-on expertise and experience in modern synthetic organic chemistry and multi-step organic synthesis.
- Hands-on experience in compound purification, acquisition and interpretation of spectroscopic data from Nuclear Magnetic Resonance (NMR), Infrared spectroscopy (IR) and Mass Spectrometry (MS) and structure determination.
- Hands-on experience in conducting multi-channel experiments for the rapid optimization of reaction parameters.
- Hands-on experience searching chemical literature and using chemical reaction databases to determine viable approaches to synthetic and mechanistic chemistry problems.
- Experience using electronic lab notebook.
- Experience with Design of Experiments (DoEs) and Quality by Design (QbD).
- Working knowledge of Good Manufacturing Practice (GMP).
- Experience in technology transfer from lab scale to kilo-lab scale or to GMP manufacture.
- Experience in manufacture of API Registration batches.
- Experience in API process Quality Risk Assessment and Regulatory Starting Material studies.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Special knowledge or skills and/or licenses or certificates preferred.
- Experience in managing CDMOs.
- Experience in API Manufacturing Validation.
- Experience in Commercial API manufacturing.
- Travel requirements
- 5 – 15%
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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- 10 Days Ago
Sr. Research Manager, Process Engineering
- Church & Dwight
-
Princeton, NJ
FULL_TIME
- A collective energy and ambition. A place where you can make a real difference.We're a company that genuinely cares about our people, our products, our consumers and the environment.Our unique, inform...
- 2 Months Ago
Senior Director, Business Development
- Everest Clinical Research
-
Bridgewater, NJ
FULL_TIME
- Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechn...
- 8 Days Ago
Director, Business Development
- Everest Clinical Research
-
Bridgewater, NJ
FULL_TIME
- Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechn...
- 10 Days Ago
Associate Director, Statistical Programming
- Everest Clinical Research
-
Bridgewater, NJ
FULL_TIME
- Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechn...
- 29 Days Ago
Director, Process & Systems
- Mondelēz International
-
East Hanover, NJ
FULL_TIME
- Job DescriptionAre You Ready to Make It Happen at Mondelēz International?Join our Mission to Lead the Future of Snacking. Make It Uniquely Yours.The Director of Processes & Systems will make an impact...
- 2 Days Ago
Process Research Director jobs at Popular Companies
Research Director
- National Louis University, IL
-
Chicago, IL
- Overview Who We Are: National Louis is a 135+ year old university that has been grounded in the values of innovation, ac...
- 6/11/2024 12:00:00 AM
Director of Research
- Stealth Cell Therapy Startup
-
Camarillo, CA
- About the Company We are a stealth biotech company co-founded by two deeply scientific Bay Area venture capital teams th...
- 6/11/2024 12:00:00 AM
Head of Research and Instruction Services
- Auburn University
-
Auburn, AL
- Posting Details Position Information Job Title Head of Research and Instruction Services Posting Number P1660F Position ...
- 6/11/2024 12:00:00 AM
Head of Research And Development
- Comrise
-
Erie, PA
- Title: Head of R&D Location: Erie, PA. 5 days onsite. Relocation Assistance Provided Responsibilities 1. Technical exper...
- 6/10/2024 12:00:00 AM
Deputy Research Director - Self-Research
- Biden for President
-
Wilmington, DE
- The Deputy Research Director for Self-Research will oversee the day-to-day management and training of the self-research ...
- 6/10/2024 12:00:00 AM
Head, Process Research
- Takeda Pharmaceutical
-
Boston, MA
- By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the...
- 6/10/2024 12:00:00 AM
Research Director
- American Urological Association
-
Linthicum Heights, MD
- The American Urological Association (AUA), the premier urologic association providing support to the urologic community,...
- 6/10/2024 12:00:00 AM
Head of Research Operations
- Takeda
-
Cambridge, MA
- Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? At Take...
- 6/7/2024 12:00:00 AM
About New Jersey
New Jersey is bordered on the north and northeast by New York (parts of which are across the Hudson River, Upper New York Bay, the Kill Van Kull, Newark Bay, and the Arthur Kill); on the east by the Atlantic Ocean; on the southwest by Delaware across Delaware Bay; and on the west by Pennsylvania across the Delaware River.
New Jersey is often broadly divided into three geographic regions: North Jersey, Central Jersey, and South Jersey. Some New Jersey residents do not consider Central Jersey a region in its own right, but others believe it is a separate geographic and cultural area from the Nor...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Process Research Director jobs
$195,285 to $283,264
Most Popular Cities in New Jersey for Process Research Director Jobs
What does a Process Research Director do?
Process Research Director in Stockton, CA
User research helps us to understand how other people live their lives, so that we can respond more effectively to their needs with informed and inspired design solutions.
December 02, 2019
Process Research Director in Pittsfield, MA
NIJ’s research and development process helps ensure that projects are relevant to the field and produce valid, actionable results.
December 05, 2019
Process Research Director in Port Arthur, TX
Throughout this process, we follow widely accepted scientific processes and procedures to help ensure the validity and integrity of our research.
December 28, 2019