- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist , CMC , R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist /Sr ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, ... with multiple agencies (FDA, EMA, JNDA, TGA).-Leadership:-Establish, manage and support CMC teams, and align resources to deliver on priorities. Manage and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... products.We are seeking a highly motivated candidate for the position of Principal Scientist (R5) focused on developing parenteral drug products across a range of… more
- Aequor (East Syracuse, NY)
- Job Title: Scientist , Analytical Sciences & Technology Contract: 12 Months Location: East Syracuse, NY Job ID: 1167 Qualifications Education / Experience / Licenses ... knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.… more
- Merck & Co. (Rahway, NJ)
- …Have experience working with CMOs and CROs.Have a working knowledge of CMC filing requirements.Demonstrate strong verbal as well as written communication skills and ... ability to work in an interdisciplinary team environment.Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.Self-motivated to take ownership and accountability of issues and drive them to completion.The… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist .BPR&D within Research Laboratories is committed to rapidly delivering diverse ... with the scientific community to influence the field.As a Senior Principal Scientist , you will drive various strategic initiatives and translate strategies into-… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Principal Scientist .BPR&D within Research Laboratories is on a mission to rapidly deliver diverse ... and engage with the scientific community to influence the field.As a Principal Scientist you will have the opportunity to influence the future direction of Upstream… more
- Merck & Co. (Rahway, NJ)
- …Combination Product Working Groups on cross-functional teams at the highest-level CMC teams and governance.Serve as key point-of-contact with potential external ... device designers, developers, and suppliers for selected device technology platforms.Oversee and serve as an integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk… more
- Insmed Incorporated (San Diego, CA)
- …to keep you challenged and engaged. If you are a driven and astute scientist who is motivated to bring life-changing medicine to patients, then this is the ... level of work quality.Ability to present scientific data and concepts to CMC team members and leadership.Knowledgeable of analytical techniques used to determine… more
- J&J Family of Companies (Malvern, PA)
- …**https://www.jnj.com/innovative-medicine** **We are searching for the best talent for a Distinguished Scientist , CMC Team Leader, Proteins to be in Malvern, PA ... or Spring House, PA.** **Purpose:** Within the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life Cycle… more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a** **Distinguished Scientist , CMC Team Leader, Protein Conjugates** **to be located ... **Malvern, PA or Spring House, PA,** **Purpose:** Within the CMC group, you will lead multiple CMC ...the CMC group, you will lead multiple CMC Teams spanning from pre-NME through post-Approval, including Life… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial Products to be a part of the Lilly ... operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and regulatory science… more
- LGC Group (Petaluma, CA)
- …an Swing Shift: Monday-Thursday (4 x 10 hours, 1pm - 11:30pm). The QC Associate Scientist brings scientific experience to LGC and is open to both learning more and ... sharing knowledge with others. You will be part of an ambitious and collaborative team that strives for flawless execution in all tasks. + Setting up instrument sequences, while monitoring analysis and data + Performing instrument troubleshooting, maintenance,… more
- Merck (Upper Gwynedd, PA)
- **Job Description** GRACS CMC - Associate Principal Scientist , CMC , R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist /Sr ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) ... for the assigned portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals and organizational initiatives, on an… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products ... make life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- ThermoFisher Scientific (Boston, MA)
- …submission sections, for late-stage and commercial programs in analytical CMC areas (eg, registrational CQAs, control strategy, justification of specifications, ... (Change Control, Impact Assessment, Change Action Owner) related to methods, CMC strategy implementation & related activities. + Perform data verification, trending,… more
- Organon & Co. (Plymouth Meeting, PA)
- …Principal Scientist will lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications and post-approval life ... **Job Description** **The Position** The Associate Principal Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry,… more
- Organon & Co. (Jersey City, NJ)
- …for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes oversight of ... development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. + Serve as the… more
