Eli Lilly

Senior Director, Drug Product CMC

Eli Lilly$153K — $290K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Ph.D. in Chemistry, Pharmaceutical Sciences, or related discipline preferred.
  • 10+ years of drug product/formulation development experience for small molecules in nonclinical and clinical settings.
  • Expertise in developing poorly soluble compounds (BCS Class II/IV) and formulation strategies for various delivery methods.
  • Strong understanding of pharmaceutical sciences and principles of dosage form development.
  • Experience managing CROs, CDMOs, and a solid grasp of cGMP requirements.
  • Excellent project management, prioritization, and organizational skills.

Responsibilities

  • Manage CROs and CDMOs to ensure effective execution of formulation studies.
  • Develop nonclinical formulations for diverse delivery methods (oral, subcutaneous, intravenous).
  • Oversee formulation stability and compatibility studies.
  • Support clinical formulation development when necessary.
  • Author and review development protocols and reports.
  • Participate in cross-functional meetings to guide on formulation and stability.
  • Coordinate supply shipments for nonclinical and clinical requirements.

Benefits

  • Eligibility for a company bonus based on performance.
  • Participate in company-sponsored 401(k) and pension plans.
  • Comprehensive medical, dental, vision, and prescription drug benefits.
  • Flexible spending accounts for healthcare and dependent care.
  • Life insurance and death benefits provided.
  • Access to wellness benefits including employee assistance and fitness programs.
Full Job Description
Centessa is seeking a Senior Director of Drug Product within the CMC group. The successful candidate will have a demonstrated, proven track record of designing high performance nonclinical and clinical formulations as well as managing CROs and CDMOs. The candidate should also have hands-on experience in developing and manufacturing nonclinical and clinical small molecule drug products to support Phase I to Phase III. Reporting to the Executive Director, CMC, this position will primarily lead work with external vendors and oversee non-clinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Travel to domestic and international vendors required. Responsibilities: • Directly manage external vendors, such as Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to: • Execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs). • Design and develop nonclinical formulations of drug candidates (oral, subcutaneous, and intravenous) to ensure stability, bioavailability and effective drug delivery in animal models. • Design and oversee execution of nonclinical formulation stability and compatibility studies. • Support clinical formulation development of oral solid dosage forms, as needed. • Author and/or review and approve development and dose preparation protocols and reports. • Review formulation related sections of protocols and reports associated with Pharmacokinetic (PK), Pharmacodynamic (PD), and safety studies. • Represent CMC and provide nonclinical formulation, DS and DP stability, and supply guidance at internal and external cross functional team meetings. • Coordinate shipments in support of nonclinical and Clinical development supply requirements to various CDMO and CRO sites. • Assist in compiling formulation-related documentation for regulatory submissions (e.g., IND, CTA) to meet non-clinical development requirements. • Work closely and collaboratively with cross-functional CMC groups including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality and regulatory, as well as other CMC functions. Minimum Qualifications: • Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. is strongly preferred. • 10+ years of drug product/formulation development experience supporting nonclinical and clinical programs, with expertise across oral, subcutaneous, and intravenous dosage forms for small molecules. • Deep technical expertise in the development and manufacture of poorly soluble (BCS Class II/IV) compounds, including formulation strategies for oral and parenteral delivery. • Strong understanding of pharmaceutical sciences and engineering principles related to liquid and solid dosage form development from early-stage development through clinical and commercial manufacturing. • Working knowledge of analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies. • Experience managing external development and manufacturing partners (CROs, CDMOs, and CMOs) and a solid understanding of cGMP requirements. • Proven ability to lead multiple complex programs in a fast-paced environment, with strong project management, prioritization, resource management, and organizational skills. • Excellent communication, presentation, and interpersonal skills, with the ability to influence stakeholders, build productive internal and external partnerships, and communicate complex scientific concepts to diverse audiences. • Strategic, hands-on leader with strong decision-making and problem-solving capabilities, demonstrated resilience, and a track record of delivering high-quality results with urgency and integrity. • Willing and able to travel domestically and internationally as needed. Work Location: • The Senior Director Drug Product CMC role is based in the US, with occasional travel. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $153,000 - $290,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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