Esperion logo
Esperion

Creative execution for today and life-saving innovation for tomorrow

Executive Director – Drug Substance Development & Manufacturing

DirectorDirectorFull TimeRemoteLeadTeam 201-500Since 2008H1B No SponsorCompany SiteLinkedIn

Location

Michigan

Posted

87 days ago

Salary

$320.5K - $365K / year

Seniority

Lead

Postgraduate Degree15 yrs expEnglishGCP

Job Description

Executive Director – Drug Substance Development & Manufacturing

Esperion

• Overall responsibility for drug substance (API) from preclinical and clinical development through process validation, site qualification, HA approval, commercial manufacturing oversight • Driving process improvements, manufacturing robustness and cost savings • Prepare and align team thinking so that regulatory starting materials (RSM’s), intermediates and API are seamlessly integrated • Site identification, selection (with QA/QC and SC) and management of Contract Manufacturing Organizations (CDMOs/CMOs) • Deliver robust, scalable and cost-effective manufacturing routes and processes for pipeline and commercial products • Execute plans for the validation, site qualification and registration of API processes at all CMO’s as required by cGMP, ICH FDA/EMA • Lead capacity expansions and technology transfers of APIs from one supplier to new suppliers on a global basis • Plan resources and develop mid to long term strategies for technical support to CMOs • Lead author, review, and approve technical reports/regulatory documents for global submissions • Responsible for preparation and management of Drug Substance Development and Manufacturing department budget

Job Requirements

  • Bachelor’s of Science Degree, with PhD preferred, in a relevant scientific discipline
  • Minimum of 15 years of experience in the pharmaceutical industry specifically in clinical and/or pharmaceutical API development and/or manufacturing
  • Minimum of 8 years of direct line management experience
  • Experience in pharmaceutical development and manufacturing with a deep understanding of the drug development process
  • Technical and scientific knowledge to direct manufacturing oversight for clinical and commercial supply activities
  • Expert knowledge in US and EU ICH/GCP, SOPs and local regulatory requirements
  • Effective oral, written communication and presentation skills
  • Team oriented style, with an ability to build collaboration and engagement among both internal and external stakeholders
  • Strong leadership skills including the ability to develop and communicate a clear strategic vision, motivate team members, and proven success in creating high performing teams

Benefits

  • Competitive salary including a performance-based bonus program and stock-based compensation
  • Comprehensive benefits package including a 401(k) matching plan and health insurance
  • Paid time off and holidays

Related Categories

Related Job Pages

More Director Jobs

Ionis Pharmaceuticals, Inc. logo

Director, Government Accounts – DGA

Ionis Pharmaceuticals, Inc.

Building on our impossible firsts, we can change the course of human health.

Director87 days ago
Full TimeRemoteTeam 501-1,000Since 1989H1B No Sponsor

• Develop and leverage strategic relationships with executives and clinical teams at Veterans Administration (VA), Department of Defense (DoD), TriCare, Prime Medicaid, Centene and targeted IDNs. • Secure and maintain access for IONIS’ products. • Develop and implement strategic business plans that optimize engagement, coverage, reimbursement of and patient access to Ionis’s products. • Assess strategic engagement and sales implications of short- and long-term actions with each payer customer. • Collaborate with Patient Services and Chanel/Distribution to ensure reimbursement confidence and unimpeded access to all in-line brands.

California
$230K - $258K / year
Job Closed
Palermo Advisors logo

Director of Marketing for a growing energy drink brand

Palermo Advisors

Borderless hiring made easy. Find world-class talent for your teams.

Director87 days ago
Full TimeRemoteTeam 1-10H1B No Sponsor

Our client is on a mission to become the #1 organic energy brand, competing in a space dominated by synthetic ingredients. Their product line delivers sustained energy through organic ingredients and a natural caffeine and nootropic blend, without jitters or crashes. Founded by a seasoned entrepreneur, they are building a passionate team to drive their next phase of growth. The Role Our client is looking for a Director of Marketing to own all marketing efforts and build a bold, authentic brand identity. Reporting directly to the CEO, this is a high-impact role for a creative, strategic doer who thrives in fast-paced startup environments. Responsibilities - Develop and execute a compelling brand strategy positioning the company as the leader in organic energy drinks, including brand voice and visual identity. - Own all marketing activities: digital campaigns, social media, content creation, influencer partnerships, and experiential events. - Plan and launch high-impact campaigns (product launches, seasonal promotions) using data-led strategies to optimize ROI. - Oversee content creation across formats (social, video, blogs) and get hands-on when needed. - Identify and manage strategic partnerships, sponsorships, and influencer collaborations. - Build and nurture community through social media, email marketing, and direct engagement. - Track and analyze key metrics (engagement, conversion, CAC) to refine strategies and drive growth. - Collaborate cross-functionally with operations, sales, and product teams. Who They're Looking For - 5+ years of experience in brand marketing, ideally in CPG, beverage, or wellness. Startup experience is a plus. - Proven ability to build and scale a brand from the ground up with creative, high-impact campaigns. - Skilled at coordinating multiple marketing channels with limited resources. - Comfortable getting into the weeds — from writing social copy to negotiating with influencers. - Data-driven, with experience using analytics tools such as Google Analytics and social media insights. - Passionate about organic and health-conscious products. - Bonus: experience with sustainable brands, community-building, or guerrilla marketing. Compensation Competitive mix of salary and equity, tailored to experience and impact. *This role is open to remote working within the US only. Only candidates based in the US will be considered. *The company name is confidential and will be disclosed during the interview process.

United States

Associate Director – Business Excellence

BeOne Medicines

BeOne Medicines, formerly known as BeiGene, is a global next-generation oncology company founded in 2010 with the vision of expanding access to high-quality can

Director87 days ago

• Ensure excellence and innovation in the delivery of BeOne’s cross-functional Customer Engagement • Work closely with the German Medical Affairs, Commercial and Market Access Leads • Assess needs in terms of staffing, capabilities, and executing activities for upskilling and scientific training • Drive business decisions whereby patient care is at the center of the business conduct • Contribute to developing and supporting the integrated launch plans and tactics in the respective countries • Support effective commercial and medical field performance across the region • Ensure the German team stays competitive using insights gathering & analysis • Support and design specific regional tactics and adapt launch strategy where needed • Apply a continuous improvement mindset to ensure solutions and improvements are rapidly identified • Collaborate extensively with the regional and local commercial, access and medical teams • Lead the development of performance metrics, and dashboards that clearly articulate the status of key activities • Incorporate innovative approaches and new digital resources that facilitate internal learning experiences • Curate, refine and create scientific training materials as needed • Stay up to date with product information, industry trend, and technology to ensure the relevance of training content • Ensure the right tools, processes and systems are in place.

Germany
Connor logo

Director – Software Publisher Services

Connor

Third-Party Compliance, GRC, Cybersecurity & Software Compliance and Advisory Solutions

Director87 days ago
Full TimeRemoteTeam 51-200H1B Sponsor

• Take ownership of a portfolio of client accounts within Software Publishers Services • Accountable for revenue, growth, and quality outcomes • Drive account-level growth and revenue extraction from existing contracts • Identify and convert upsell and cross-sell opportunities • Pursue net-new client acquisition through your professional network and market presence • Maintain periodic senior-level touchpoints with clients • Ultimately accountable for the quality standard clients experience • Lead net-new client acquisition in the software license compliance space

California
$115K - $140K / year