Senior Manager Contract Manufacturing Specialists Team Lead
About the job
- Doctorate degree with 2 years of directly related experience, or a master's degree with 6 years of directly related experience, or a bachelor's degree with 8 years of directly related experience.
- At least 8 years of experience in a protein, active pharmaceutical ingredient, drug substance, drug product, or packaging manufacturing environment.
- At least 8 years of working knowledge of current Good Manufacturing Practice principles, Food and Drug Administration and other regulatory guidelines, and validation principles.
- At least 5 years of experience in a people leadership and team management role.
- Ability to operate effectively amid ambiguity and complexity, multitask, and consistently deliver quality results.
- Experience leading cross-functional and matrixed teams, with effective writing, presentation, and interpersonal skills to address a broad range of audiences.
- Willingness to travel as needed to support business requirements.
- Oversee budget development, monitoring, and reporting for manufacturing operations.
- Provide input to contracts, confidentiality disclosure agreements, scopes of work, requests for pricing or information, supply agreements, and related documents.
- Own and coach staff on managing deviations, corrective and preventive actions, corrective and preventive action effectiveness verification, and complex change control records.
- Report contract site performance metrics and identify opportunities to improve site performance.
- Analyze data and metrics, drive continuous improvement and standardization of team performance tools, oversee procurement and invoice payments, and actively participate in meetings with contract sites and internal site teams.
- Oversee department-wide projects from conception through implementation and close-out.
- Manage technology transfer team activity timelines, highlight risks, coordinate transfer risk management, and escalate issues to the appropriate level.
- Lead continuous improvement initiatives to streamline business processes, enhance operational efficiency, and strengthen data-driven decision-making.
- Identify, evaluate, and implement practical artificial intelligence-enabled solutions to improve workflow standardization, reduce manual effort, and drive consistent execution across internal teams and external manufacturing partners.
About the company
Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.
Company Size
10,001+
Company Stage
IPO
Headquarters
Thousand Oaks, California
Founded
1980
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Simplify's Take
What believers are saying
- Growth is broad-based: 22 products grew at least 10%, lifting June 2026 quarter revenue 10% to $10.1 billion.
- Stock grants gained value: Amgen shares rose 27% from January to October 9, 2026, versus 10% for rival Eli Lilly.
- Many U.S. roles are remote: 145 of Amgen's 615 U.S. job openings in October 2026 were fully remote.
What critics are saying
- Its 2025 best seller is shrinking: cheaper copies cut bone drug Prolia's sales 32% in the June 2026 quarter.
- MariTide, Amgen's obesity bet, faces a giant: Lilly's Mounjaro and Zepbound outsold all of Amgen in the June 2026 quarter.
- Most tech openings are in India: 156 of Amgen's 210 information systems jobs in October 2026 were in Hyderabad.
What makes Amgen unique
- It copies rivals' blockbusters too: Pavblu, its version of Regeneron's eye drug Eylea, sold $700 million in 2025.
- Amgen hunts drug targets in a nation's DNA: its Icelandic unit deCODE has genetic data on two-thirds of Iceland's adults.
- Amgen opened a U.S. cancer-drug class: Blincyto, approved in 2014, was the first to tether immune cells to cancer.
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Company News
Amgen is testing MariTide, an experimental obesity drug designed to be dosed monthly or less frequently. The therapy has advanced into late-stage Phase III trials, with nine studies currently running and three more planned. Executives reported strong enrolment during the company's second-quarter 2026 earnings call on 4 August 2026. Amgen expects capital spending of about $2.6 billion in 2026, partly to scale manufacturing capacity for MariTide's eventual launch. The company is investing across its US manufacturing sites in North Carolina, Ohio, and Puerto Rico. Amgen stock has returned 44% over the past twelve months, outpacing the S&P 500's 17.1% gain. The company reported $38.1 billion in revenue over the last twelve months, up from $34.9 billion a year earlier.
Amgen raised its quarterly dividend 6% to $2.52 per share, marking its 14th consecutive annual increase since starting payouts in 2011. The biotech now pays $10.08 annually, yielding 2.36% at current share prices of $418.13. The dividend appears well covered. Amgen generated $8.1 billion in free cash flow in 2025 against $5.1 billion in dividend payments. Second quarter 2026 free cash flow reached $3.5 billion whilst dividends consumed $1.4 billion. However, biosimilar competition is eroding legacy revenue. Prolia and XGEVA sales dropped 33% whilst Enbrel fell 37%. The company carries $57 billion in debt. Future dividend growth may hinge on Phase 3 results for MariTide, Amgen's obesity candidate. The company follows a steady raise pattern similar to Johnson & Johnson, contrasting with Pfizer's post-COVID payout struggles.
Vertex Pharmaceuticals reported strong second-quarter results, with revenue rising 12% year-over-year to $3.33 billion and earnings per share climbing 8% to $4.31. The company posted positive Phase 2b results for inaxaplin, an experimental treatment for APOL1-mediated kidney disease, showing it reduced proteinuria in patients with modest protein levels and those with type 2 diabetes. Vertex expects approval for povetacicept, a treatment for IgA nephropathy, by November. The company continues diversifying beyond its core cystic fibrosis franchise, which provides predictable revenue as patients require lifelong treatment. Meanwhile, Amgen has also outperformed the broader market this year, though specific recent developments were not detailed in the source material.
Revolution Medicines received FDA approval for daraxonrasib, the first targeted therapy for metastatic pancreatic cancer, after clinical data showed it reduced death risk by more than half. The company is clinical-stage with no current revenue and posted a $1.1 billion net loss in FY 2025. Amgen reported FY 2025 revenue of $36.7 billion, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. Free cash flow reached $8.1 billion. The company carries a debt-to-equity ratio of 6.3x. Revolution Medicines maintains a 0.1x debt-to-equity ratio and 9.5x current ratio but recorded negative free cash flow of $913.7 million. The company's pipeline targets RAS-driven tumours including lung cancer. A partnership with Royalty Pharma provides funding for development. Both companies face distinct risks: Amgen confronts pricing pressures and biosimilar competition, whilst Revolution Medicines carries clinical trial failure risks and competes against larger pharmaceutical firms.
Amgen reported revenue of $36.7 billion in FY 2025, up 9.9% year-over-year, with net income of $7.7 billion and a 21% net margin. The biotech giant maintains a debt-to-equity ratio of 6.3x and generated $8.1 billion in free cash flow. CRISPR Therapeutics, meanwhile, saw revenue fall 90% to $3.5 million in FY 2025, posting a net loss of $581.6 million. The gene-editing firm burns $345.9 million in cash but holds a strong current ratio of 13.3x. Its CASGEVY therapy for sickle cell disease has gained approval in the US, UK, and EU, with Vertex handling commercialisation under a 60-40 revenue split. Amgen faces pricing pressure from the Inflation Reduction Act and biosimilar competition. CRISPR Therapeutics carries clinical execution risk and ongoing intellectual property disputes.