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With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies.

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.Remote working, contract opportunities for technical writers in the following areas for pharma manufacturing.The six workstreams:<ul><li>Contamination Control and Environmental Monitoring</li><li>Manufacturing/Production Controls</li><li>Data Integrity and Data Governance</li><li>Facilities and Utilities</li><li>Quality Systems</li><li>Laboratory Controls</li></ul>We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.<ul><li>ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*</li></ul>

ProPharma Group Holdings LLC

Quality Manufacturing Technical Writer (Remote working)

Artificial Intelligence (AI)

Biotech and Pharmaceutical

Clinical Research

Consulting

Data Quality

Diversity

Drug Manufacturing

Environmental Monitoring

Manufacturing

Manufacturing Technology

Medical Records

Pharmacovigilance

Product Lifecycle

Production Control

Regulations

Research & Development (R&D)

Risk

Scientific Research

Technical Writing

To support commercialization of our late-stage drug candidate, the CMC team is seeking an experienced manufacturing leader with deep small molecule expertise to provide strategic planning and operational oversight across our bulk product supply chain. Work hands-on to seamlessly manage manufacturing operations at external suppliers, including contracting, scheduling of production to meet forecast demand, change control and deviation management, and issue escalation.

Overview   Priovant is committed to developing therapies that address high unmet need in autoimmune disease. To support commercialization of our late-stage drug candidate, the CMC team is seeking an experienced manufacturing leader with deep small molecule expertise to provide strategic planning and operational oversight across our bulk product supply chain. The successful candidate will work directly with our external manufacturing partners, ensuring seamless product flow and robust commercial supply. The Senior Director, Commercial Manufacturing reports to the Senior Vice President, CMC. The position is remote, with domestic and international travel required as necessary to oversee activities at manufacturing partners, and to meet with the team periodically at our Durham, NC office.  Responsibilities  <ul><li>Strategically build and manage the commercial supply chain for small molecule pharmaceutical products, including starting materials, drug substance, and bulk drug product. </li><li>Work hands-on to seamlessly manage manufacturing operations at external suppliers, including contracting, scheduling of production to meet forecast demand, change control and deviation management, and issue escalation. </li><li>Lead product pricing negotiations, establish supply agreements, collaborate with legal to maintain relevant contracts, and manage the budget for bulk product manufacturing. </li><li>Partner with drug substance and drug product technical leads to expand production to additional sites as required to meet demand and globally minimize supply chain risk. </li><li>Collaborate with Regulatory to assure compliance of manufacturing activities with global regulatory requirements and filed product information. </li><li>Partner with Quality to author and implement relevant policies and operating procedures, maintain quality agreements, monitor for gaps, and establish appropriate mitigation strategies to ensure global product quality. </li></ul> Qualifications  <ul><li>BS or BA in chemistry, chemical engineering, or related scientific discipline, with at least 12 years of small molecule manufacturing experience. </li><li>Top-tier expertise in managing external production networks for bulk pharmaceutical products, with a proven track record of working successfully with commercial manufacturing partners.  </li><li>Detailed understanding of drug substance manufacturing, including the ability to review executed batch records, understand the impact of analytical test results, and manage deviations. </li><li>Ability to participate in complex commercial supply negotiations, critically review service agreements, and assure quality agreements align with operational goals.  </li><li>Current knowledge of relevant global regulatory requirements that could impact production, testing, release, or distribution of products. </li></ul>

Hybrid Production Jobs in Raleigh, NC

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Hybrid Production Jobs in Raleigh, NC

Quality Manufacturing Technical Writer (Remote working) ProPharma Group Holdings LLC

Senior Director, Commercial Manufacturing Priovant Therapeutics

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