Senior Director Process Engineering Peptides API
About the job
- A bachelor's degree in Engineering, Science or a relevant technical discipline is required.
- Typically 15 or more years of relevant engineering, manufacturing, capital project, technical operations or regulated manufacturing experience is required.
- Demonstrated technical capability in biologics drug substance and cell and gene therapy process engineering strategy, process platform deployment, process package design, technical assurance, manufacturing technology interfaces and project delivery is required.
- Demonstrated ability to work across global functions, manufacturing sites, project teams, suppliers, vendors and external engineering partners is required.
- Strong communication, risk management, technical judgment, stakeholder engagement and structured problem-solving skills are required.
- Technical competency in biologics drug substance and cell and gene therapy process design and process package review is required.
- Technical competency in front-end engineering and concept development is required.
- Technical competency in biologics and cell and gene therapy technology transfer, platform deployment and manufacturing scale-up is required.
- Technical competency in process safety and commissioning, qualification and validation interfaces is required.
- Technical competency in Strategic Investment support, strategic capital investment and new biologics or cell and gene therapy technology deployment support is required.
- Technical competency in engineering governance, standards development and deployment requirements for emerging biologics drug substance and cell and gene therapy manufacturing technologies is required.
- Technical understanding of bioreactor, harvest, purification, single-use, closed processing, aseptic processing, viral vector, cell processing and cryogenic or cold-chain interfaces is required as applicable to biologics and cell and gene therapy platforms.
- Technical competency in technical risk management, project execution support, stakeholder management, vendor and partner technical coordination, good manufacturing practice and regulated manufacturing awareness, and operational readiness and handover support is required.
- The role requires strategic thinking, an enterprise mindset, matrix leadership, influence without direct authority, clear technical communication, executive-ready recommendations, risk-based decision-making, issue escalation, cross-functional collaboration, capability building, mentoring and knowledge sharing.
- The role requires continuous improvement and commitment to safety, quality and compliance.
- Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics drug substance and cell and gene therapy process engineering and project delivery.
- Drive consistent application of technical standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects.
- Define enterprise standards, engineering requirements and technical guardrails for new biologics drug substance and cell and gene therapy technologies.
- Provide governance and escalation for technical decisions affecting safety, quality, compliance, cost, schedule, operability or lifecycle outcomes.
- Provide engineering leadership for strategic capital investments, facility builds, technology platform deployments, new production capabilities, strategic capacity projects and lifecycle technology upgrades.
- Support front-end engineering, facility concept development, investment option evaluation, manufacturing capability assessments and site or platform planning activities.
- Partner with Strategic Investments and project leadership to integrate technical assumptions, deliverables, risks and resource needs into capital program plans.
- Lead or support technical decision-making across multiple manufacturing sites, capital projects and technology platforms.
- Ensure engineering deliverables support safety, quality, compliance, operability, maintainability, reliability, sustainability and operational readiness.
- Coordinate technical input from project teams, site subject-matter experts, external engineering partners, vendors and cross-functional stakeholders.
- Drive timely resolution of technical issues and escalate decisions with broader project, network or business impact.
- Partner with Strategic Investments, manufacturing operations, quality, validation and commissioning, qualification and validation, environment health and safety, site engineering, manufacturing science and technology, supply chain, finance and related engineering disciplines.
- Ensure discipline decisions are integrated with manufacturing strategy, network capacity, technology platform deployment, regulatory expectations and site handover needs.
- Represent Strategic Investment in technical reviews, project forums and risk discussions.
- Share engineering best practices, lessons learned and technical knowledge across sites, regions and projects.
- Build capability through coaching, mentoring, technical review discipline and development of reusable engineering practices.
- Support continuous improvement of Strategic Investment standards, templates, knowledge management and project delivery approaches.
- Collaborate across Strategic Investments to identify, develop and deploy best practices, technical standards, lessons learned and capability-building initiatives.
- Promote consistency, quality, reliability, sustainability and project delivery performance across regions, sites and capital projects.
- Support long-range manufacturing strategy, strategic investment planning and Strategic Investment capability development.
- Lead, coach and develop a high-performing technical engineering team with clear priorities, accountability, development plans and delivery expectations.
- Set technical direction for the engineering team and prioritize work against safety, quality, compliance, business value, capital delivery needs and long-range manufacturing strategy.
- Build technical bench strength by identifying capability gaps, developing succession depth, mentoring senior engineers and enabling knowledge transfer.
- Create an inclusive and disciplined technical decision-making environment where engineers challenge assumptions, manage risk transparently and escalate material decisions.
- Align team performance with enterprise standards by reinforcing consistent engineering practices, structured technical reviews, lessons-learned adoption and measurable delivery outcomes.
- An advanced degree is preferred where relevant.
- Experience supporting biologics drug substance, cell therapy, gene therapy, viral vector, messenger RNA, sterile biologics or similarly regulated biopharmaceutical manufacturing environments is preferred.
About the company
AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.
Company Size
10,001+
Company Stage
IPO
Headquarters
North Chicago, Illinois
Founded
1888
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Simplify's Take
What believers are saying
- Apogee acquisition closed in 2026, expanding AbbVie’s immunology pipeline beyond Skyrizi and Rinvoq.
- EU approvals for RINVOQ and EPKINLY in September 2026 broaden ex-U.S. revenue.
- JUVMO launches in October 2026, adding a fresh neuroscience revenue line.
What critics are saying
- Humira, Skyrizi, and Rinvoq concentration keeps AbbVie exposed if immunology growth slows in 2027.
- Niaspan antitrust MDL and Biocell ALCL settlements carried $1.7 billion litigation accrual by June 2026.
- Generic ubrogepant and atogepant suits threaten Ubrelvy and Qulipta exclusivity within years.
What makes AbbVie unique
- Skyrizi and Rinvoq anchor AbbVie’s post-Humira immunology franchise across 11 EU RINVOQ indications.
- JUVMO’s September 28, 2026 FDA approval gives AbbVie first-in-class Parkinson’s D1/D5 therapy.
- AbbVie pairs blockbuster cash flows with Apogee, Iambic, and Valkai deal-making.
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Benefits
Remote Work Options
Flexible Work Hours
Professional Development Budget
Growth & Insights and Company News
6 month growth
4%1 year growth
5%2 year growth
5%A Motley Fool comparison of AbbVie and Novo Nordisk concludes AbbVie is the better long-term buy in 2026, even though Novo looks cheaper. AbbVie's 2025 revenue rose about 8.6% to $61.2 billion, but net income was $4.2 billion. Novo Nordisk's revenue grew 6.4% to $46.3 billion, with net income of $15.3 billion. Novo trades at 11.7 times forward earnings against AbbVie's 20.2. Analysts expect Novo's 2026 sales to fall about 3% on pricing pressure and rivalry from Eli Lilly. AbbVie is forecast to grow net income to $14.6 billion on $67.2 billion in sales, helped by its $10.9 billion Apogee Therapeutics deal and its Skyrizi and Rinvoq drugs.
AbbVie shares have climbed to $281.12, up 9.33% in a month and 22.59% so far this year, after a run of clinical and regulatory news. Total shareholder return is 25.85% over one year. The news includes Phase 3 Crohn's disease results for SKYRIZI and RINVOQ, and FDA Breakthrough Therapy Designations for Temab-A in colorectal and lung cancer. AbbVie also released early obesity data for ABBV-295 and Phase 2 atopic dermatitis results for zumilokibart. Simply Wall St's most followed narrative puts fair value at $278.61, leaving the stock 1% overvalued. Its discounted cash flow model estimates $497.77, which would put the shares about 43.5% below fair value. Risks include tighter drug price pressure and faster than expected competition for Skyrizi and Rinvoq.
A comparison of AbbVie and Eli Lilly favours Eli Lilly for long-term investors, driven by its strong weight-loss and diabetes drug franchise. Lilly's 2025 revenue rose 44.7% to $65.2 billion, with net income of $20.6 billion. AbbVie's revenue grew 8.6% to $61.2 billion, with net income of $4.2 billion, as Skyrizi and Rinvoq replace ageing Humira sales. Lilly trades at a forward price-to-earnings ratio of 33.1x, against 19.8x for AbbVie. Lilly expects 2026 revenue of up to $85.2 billion, helped by Zepbound, Mounjaro and a new pill, Foundayo. AbbVie forecasts 2026 sales of $67.2 billion and net income of $14.6 billion. It is also acquiring Apogee Therapeutics.
AbbVie's dividend yield has fallen to about 2.6%, its lowest since early 2018. The drop comes from a share price that has risen faster than the dividend, not from any cut. The drugmaker has raised its dividend for 54 consecutive years, including its time as part of Abbott Labs. The payout is up almost 333% since 2013, while the stock has gained roughly 676%. Growth looks set to continue. Humira's successors, Skyrizi and Rinvoq, are on track for combined 2026 sales of over $29 billion, against Humira's peak of about $22 billion in 2021. If dividend growth matches the past five years' pace, yield on cost could top 4.6% within 10 years. Consensus analyst targets imply only about 5% upside over 12 months.
AbbVie's experimental cancer drug Temab-A earns two FDA breakthrough designations for advanced colorectal and lung cancers. Published Oct 10, 2026 1:50 PM EDT By Elena Vega The FDA has granted two Breakthrough Therapy designations to telisotuzumab adizutecan, or Temab-A, an experimental AbbVie drug for advanced colorectal and lung cancers, the company announced in a press release on Oct. 7. The status can speed the drug's development and review, but it is not an approval. One designation covers Temab-A combined with bevacizumab for adults with metastatic colorectal cancer that keeps progressing after standard chemotherapy and targeted drugs. The other covers Temab-A alone for adults with advanced non-squamous non-small cell lung cancer that is EGFR wild-type and expresses the c-Met protein, after platinum chemotherapy and immunotherapy. For families of patients who have run through standard options, the news offers a possible future treatment, not an immediate one. AbbVie's announcement did not include efficacy figures, and the drug is still being tested. A targeted drug built around c-Met. Temab-A is an antibody-drug conjugate. It pairs an antibody that seeks out c-Met, a protein found at higher levels on many tumors, with a chemotherapy-like payload that blocks an enzyme cancer cells need to copy DNA. The design aims to deliver the payload directly to tumor cells while limiting exposure elsewhere. "These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors," said Dr. Eleni Lagkadinou, vice president of oncology early development at AbbVie. She added that Temab-A "has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations." The company said both designations were based mainly on its first-in-human phase 1 study, known as M21-404. These are the first breakthrough designations for Temab-A, and AbbVie said its antibody-drug conjugate portfolio now holds four. Beyond colorectal and lung cancer, the company is testing Temab-A in head and neck, gastroesophageal, pancreatic, and ovarian cancers through several phase 3 and phase 2/3 studies. Early numbers behind the colorectal designation. Earlier data offer some context. In results presented at the 2025 European Society for Medical Oncology Congress and summarized by OncLive, 30 patients given the higher Temab-A dose with bevacizumab went a median 6.8 months before their cancer worsened. That compared with 4.2 months for 20 patients on a standard regimen of trifluridine/tipiracil plus bevacizumab. Median overall survival had not yet been reached in the higher-dose group, compared with 9.6 months in the standard-care group. A third group of 26 patients on a lower Temab-A dose went a median 5.6 months before progression and lived a median 9.8 months. Those numbers came from a data cutoff in May 2025, so longer follow-up could change the picture. Those groups were small, and patients were not selected by c-Met levels. Side effects were common. Among 63 patients who received Temab-A, 37% had severe (grade 3 or higher) anemia, and nausea, fatigue, and vomiting each affected 40% or more. Lung inflammation occurred in 5%, including one severe case. MedicalDaily Evidence Check: The evidence comes from an early-phase, company-sponsored trial reported at a medical conference and in a company press release. No independent experts were quoted in AbbVie's announcement, and comparable published data for the lung cancer designation were not provided. Breakthrough status is not approval. The FDA describes Breakthrough Therapy designation as a process to speed the development and review of drugs for serious conditions when preliminary evidence suggests substantial improvement over available therapy. It brings more intensive FDA guidance, but the drug still has to prove itself in larger trials. Companies request the designation, and the FDA responds within 60 days. That test is underway. The phase 3 AndroMETa-CRC trial compares Temab-A plus bevacizumab with trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer, with response rate and overall survival as primary goals. A key secondary goal is whether survival differs by c-Met levels, which could help clarify which patients benefit most. AbbVie has not announced a filing timeline. The need is real. The American Cancer Society estimates about 55,230 Americans will die of colorectal cancer in 2026, and the group's 2026 report found that 45% of new cases occur in adults under 65. AbbVie noted that colorectal and lung cancer together affect more than four million people worldwide each year. The people most directly affected are those who have already exhausted several lines of treatment. For colorectal cancer, that means patients whose disease progressed after fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF drug, and, when appropriate, an anti-EGFR drug. For lung cancer, the designation applies only to tumors without EGFR mutations that test positive for c-Met protein, a smaller group of patients. Options for patients today. Patients with advanced colorectal or lung cancer can ask their oncologist whether a Temab-A trial or another study fits their situation. Lung cancer patients may also ask whether their tumor has been tested for c-Met protein expression and EGFR mutations, since both results determine whether the lung cancer designation would apply to them. AbbVie lists an expanded access program for Temab-A, generally for people who do not qualify for trials and lack other suitable options. A doctor must decide whether the potential benefit outweighs the risk, and availability depends on location. Anyone considering a trial should ask which costs the sponsor covers and which fall to insurance, along with how often travel to a study site would be needed. No one should stop current treatment without speaking with their care team. What comes next depends on the phase 3 results. A breakthrough designation can shorten the path to a decision, but AbbVie still has to file for approval, and the FDA still has to judge whether the benefit outweighs side effects like anemia and lung inflammation. Until then, Temab-A is available only through research settings. Key questions answered. What is Temab-A? Temab-A, or telisotuzumab adizutecan, is an experimental antibody-drug conjugate from AbbVie that targets the c-Met protein on tumor cells and delivers a cell-killing payload. Is Temab-A approved? No. Breakthrough Therapy designation speeds development and review, but the drug has not been approved by the FDA or any other regulator. Which patients do the designations cover? Adults with previously treated metastatic colorectal cancer, when Temab-A is combined with bevacizumab, and adults with previously treated, c-Met protein-expressing, EGFR wild-type non-squamous lung cancer. How well does it work? AbbVie released no new efficacy data. Earlier phase 1 results showed a median 6.8 months without colorectal cancer progression in a small group, compared with 4.2 months on standard treatment. How can patients get access? Patients can ask their oncologist about clinical trials, including the phase 3 AndroMETa-CRC study, or about AbbVie's expanded access program. Published by Medicaldaily.com