Pharmaceutical jobs in Boston, Massachusetts - Page 2Crear alertas

主要职责： 项目技术转移 • 主导多个生物药项目（涵盖上游培养、下游纯化、制剂灌装）的技术转移全流程，制定分阶段策略并监督执行。, • 审核技术转移文件（工艺描述、风险评估、分析报告），组织跨部门（PD、生产、QA/QC）会议以确保技术细节有效落地。, • 起草核心文件（差距分析、转移方案、总结报告），并全程跟踪物料、设备、工艺规程等关键节点。, • 为商业化生产提供工艺优化建议，参与复杂偏差调查及工艺验证（PPQ） 注册申报支持, • 撰写BLA/NDA申报资料（如CMC模块、工艺验证报告），支持全球监管机构问询。 教育背景 • 研究方向与 生物药工艺开发 （如细胞培养、蛋白纯化、制剂稳定性）或 GMP生产 相关者优先。, • 发表过相关领域SCI论文或专利者优先。, • 了解生物药生产工艺（哺乳动物细胞培养、层析、超滤/透析、无菌灌装）及关键质量控制点。, • 掌握技术转移方法论（如风险评估工具FMEA、质量源于设计QbD）。, • 逻辑与解决问题： 擅长系统性思维，能通过DOE等工具解决复杂工艺问题。, • 沟通与协作： 具备优秀的跨文化沟通能力，能清晰地向非技术部门传递技术信息。, • Lead end-to-end technology transfer for multiple biologics projects (upstream, downstream, fill-finish), defining phase-appropriate strategies and overseeing execution., • Review and align cross-functional teams (PD, Manufacturing, QA/QC) on transfer documents including process descriptions, risk assessments, and analytical reports., • Draft critical transfer documents such as gap analyses, protocols, and summary reports; track key milestones including materials, equipment, and batch records., • Resolve deviations and change controls, drive root cause analysis (RCA), and implement CAPA., • Provide process optimization recommendations for commercial manufacturing and support complex deviation investigations and process validation (PPQ)., • Author BLA/NDA submission documents including CMC sections and process validation reports; respond to global health authority (FDA/EMA/NMPA) queries., • Ph.D. in Biopharmaceutical Engineering, Molecular Biology, Pharmaceutical Sciences, or related field., • Research background in biologics process development (cell culture, protein purification, formulation stability) or GMP manufacturing., • Published papers or patents in related fields (SCI journals preferred)., • Industry or academic project experience in GMP production or pilot-scale process scale-up., • Knowledge of biologics manufacturing processes including mammalian cell culture, chromatography, UF/DF, and aseptic filling; understanding of critical quality attributes (CQAs)., • Familiar with technology transfer methodologies such as FMEA and QbD; knowledge of GMP/ICH guidelines., • Experience in process validation or regulatory writing is a strong advantage., • Systematic problem-solving ability with experience using DOE or statistical tools (e.g., JMP, Minitab)., • Able to clearly convey technical concepts to non-technical stakeholders., • Effective in fast-paced environments, skilled at multitasking and managing priorities. Suzhou, Guangzhou, or Lianyungang, China

Sr. Manager, Clinical Pharmacology 6 month contract Must be able to work on a W2 Hybrid in Waltham, MA 3x per week We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join the team supporting the CNS therapeutic area as a key member of the Clinical Pharmacology, DMPK, and BA department. This individual will represent the function as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams. The position includes core scientific responsibility for selecting optimal doses and dosage regimens in patients, integrating knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role offers the opportunity to support multiple programs through participation on internal project working teams and will serve as a liaison between chemistry, life sciences, regulatory, and clinical operations. Hands-on modeling experience is desirable. Requirements • Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions., • Conduct and oversee pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modeling., • Present strategy and defend outcomes of model-based approaches to internal governance boards and regulatory agencies., • Write or review clinical pharmacology components of regulatory documents and responses; participate directly in regulatory interactions., • Promote model-informed drug discovery and development through external collaboration, journal publication, and conference presentation., • Function effectively in a highly matrixed team environment., • Serve as an active contributor on multi-disciplinary project teams, providing innovative and progressive input., • Act independently within a highly matrixed clinical development organization and provide sound clinical pharmacology input to project teams. Qualifications • Ph.D. or PharmD in Pharmaceutical Sciences, Pharmacometrics, or related field with 3+ years or 4+ years of pharmaceutical industry experience., • Demonstrated experience serving as a clinical pharmacology lead on development programs., • Strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing current computational tools., • Working knowledge of cross-functional interfaces relevant to drug development and detailed understanding of non-clinical and clinical DMPK processes., • Programming experience in Phoenix required; additional experience in Monolix, R, WinNonlin, SAS, or Splus is desirable., • Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; direct interaction with FDA including IND, NDA, and other submissions required., • Experience in non-compartmental and model-based PK and PK/PD analyses and incorporating data into manuscripts, study reports, and regulatory submission documents (INDs, NDAs, CTDs)., • Excellent interpersonal, leadership, communication, and time-management skills; demonstrated experience managing internal and external personnel (including outsourced projects)., • Clinical pharmacology experience with small molecules desired., • Experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME desired., • Knowledge and experience in CNS therapeutics desired., • Hands-on modeling experience desirable.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education/ Experience MD, combined MD/PhD or internationally recognized equivalent plus 5 years of clinical research experi

Lead insight-driven decision-making, converting market intelligence into a compelling brand narrative; leverage analytics to validate opportunities, optimize marketing mix, and maximize ROI on brand investments. Bachelor's degree with 10+ years of progressive pharmaceutical experience in marketing,

Minimum of 3 years in pharmaceutical manufacturing, familiar with cGMP requirements. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

The HIV Area Business Manager (ABM) is part of the US Endocrinology Therapeutic Area and is responsible for promoting Serostim®, a product indicated for treating HIV patients with wasting or cachexia to increase lean body mass, body weight, and improve physical endurance. Knowledge of scientific an

Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Norstella serves most pharmaceutical and biotech companies around the world, along with regulators like the FDA, and payers.

Executive Director, Strategic Business Development. With a strong understanding of the clinical development lifecycle and deep relationships within the pharmaceutical industry, the Exec Director, Strategic BD partners closely with internal stakeholders across therapeutic strategy, operations, legal,

We are seeking a visionary Director to lead our Data Science team, transforming pharmaceutical commercialization with advanced data science and AI. AI/ML modeling, with at least 5 years in a pharmaceutical commercial analytics or healthcare setting required. At Takeda, we are transforming patient ca

The ideal candidate will have over 7 years of experience in analytics and pharmaceutical marketing analytics expertise. This full-time role promises a vital impact on marketing strategies while offering benefits such as medical and vision insurance and a 401(k).

The Executive Director, US Access Strategy & Marketing, CNS leads the Access Strategy and Marketing team responsible for the development of U. Experience working closely with other functions such as Pricing & Contracting, Marketing, Sales, Medical Affairs, and Government Affairs to ensure alignment

Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences(DQS) is committed to harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. Delivery & Business Accountabilities: • Lead delivery for one or more assets at GPT level or specialty area in clinical, • Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors, • Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission, • Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation, • Create an internal cross functional and external with vendors sphere of influence in predictable delivery, • Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them Contributions: • Asset-level GPT strategy and delivery, • Broadly DQS functions, • Parts R&D functions. Core Elements Related to this Role: • Advanced knowledge of clinical study designs, analysis methodology and data interpretation., • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function., • Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions., • Strong statistical programming skills, • Excellent oral and written communications skills., • Specialized statistical expertise in multiple therapeutic areas or development phases., • Strong inter-personal and people management skills., • Strong project management skills., • Strong collaborative skills and ability to work with a cross-functional team. Technical/Functional (Line) Expertise: • Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics, • Scientific understanding of drug R&D to inform methodological input with product team or in a platform, • Strong communication skills and ability to translate effectively across functional lines, • Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs that he/she is involved in Leadership: • Lead one or more assets at GPT level or specialty area in preclinical, clinical, translational, • Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D, • Enable the tactical execution of the SQS and DQS vision and mission, • Lead and be accountable for asset level strategies being implemented, • Demonstrate mentorship, matrix or direct management of small team of SQS colleagues, • Create an internal and external sphere of influence in area of expertise Education: • PHD with ~ 5 years experience, • MS with ~ 8+ years experience Behavioral Competencies: • Inspire teamwork, • Assess benefit risk of options, • Develop understanding of business beyond SQS, • Focuses on priorities

We are seeking a professional CDL Driver with Hazmat endorsement to safely transport radioactive Class 7 materials and temperature-controlled pharmaceuticals. Valid CDL Class A or B license with Hazmat (H) endorsement. Minimum [X years] of verifiable CDL experience; prior Class 7 or pharmaceutical t

The Executive Director, US Brand Lead, Neurology Therapeutic Area will lead the US launch with accountability for pre-launch activities and execution of commercial launch. Executive Director, US Brand Lead, Neurology.

Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences. Bachelor's degree in Chemical Engineering or a related pharmaceutical science with 11+ years of relevant industry experience. Master's degree in Chemical En

Marketing techniques - comprehensive understanding of pharmaceutical marketing methods, tools and concepts. Extensive experience in both marketing strategy and marketing execution. Salesforce national meeting marketing execution.

Five or more years' experience in the pharmaceutical or healthcare sector with evidence of successful outcomes.

Chemical Engineering or a related pharmaceutical science with 0+ years of relevant industry experience. Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with method

The Senior Engineer, SAP (Business Objects Data Services) is responsible for designing, developing, and maintaining complex data integration and migration solutions, working on various data conversions for an SAP implementation across pharmaceutical, medical, and nuclear segments. ETL & Data Tools:

IPM partners with clients across the life sciences industry sectors, including pharmaceuticals, medical technology, and biotechnology, which includes large-molecule proteins, monoclonal antibodies, cell, tissue, and genetic therapies, and molecularly engineered vaccines. As a Consultant, you will pa

Familiarity with the commercial sales /product launch process for pharmaceuticals strongly preferred. An active connector and networker with strong knowledge and relationships within the pharmaceutical / healthcare industry.

Strong software sales background, with proven track record of closing complex software sales cycles. Application Sales Representative. Recruiting for an Application Sales Representative to sell software and cloud services into a select list of pharmaceutical and medical device companies in the USA.

Security Officer - Pharmaceutical Perimeter Patrol. As a Security Officer - Pharmaceutical Perimeter Patrol in Waltham, MA, you will serve and safeguard clients in a range of industries such as Healthcare, and more.

Direct experience in the pharmaceutical industry or a specific focus on Medical Affairs is highly desirable. You are knowledgeable about the pharmaceutical regulatory and compliance environment, including guidelines and codes such as the PhRMA Code.

Knowledge of current industry trends and emerging technologies in the R&D and Pharmaceutical Sciences + Ability to propose and prioritize future technical investments, assessing trade-offs between technical risks and potential benefits/rewards. Job Description** _Objective / Purpose:_ The Head o

See Takeda Pharmaceutical Terms of Use at . At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Lead activities in partnership with Pharmaceutical Sciences and/or Operating Units, including:. Lead cross-functional teams and effectively influence key stakeholders—including Pharmaceutical Sciences, Plasma Derived Therapies R&D, GMS Operating Units, and CMOs—to drive alignment, decision-makin

A leading oncology pharmaceutical company in Boston is seeking a dynamic Senior Project Manager to support strategic outcomes within CMC Operations.This role involves creating project plans, managing budgets, and ensuring project success through stakeholder engagement and risk management.Ideal candi

DuPont has an exciting and challenging opportunity for an Account Manager for Healthcare Packaging - Medical Device Manufacturer (MDM) & Pharmaceutical in the North America DuPont Tyvek Healthcare Roll Goods segment. This role will maintain and expand relationships with strategic value chain partner

Provide strong leadership for the following activities, along with Pharmaceutical Sciences and/or Operation Units: API Manufacturing Process Characterization, Technology Transfer from/to external CMOs and/or internal manufacturing sites. Pharmaceutical Sciences counterparts. Must have sound understa

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

As the Director, Technology Business Partner for Pharmaceutical Sciences R&D Data Digital and Technology (R&D DDT), you will serve as a strategic and trusted partner to PharmSci, driving digital transformation in alignment with scientific and operational priorities. Serves as a strategic advisor and

Pharmaceutical industry within the Americas, working with teams across Sales, Product, Service, Global to influence and support efforts impacting Pharmaceutical customers and our ability to educate and engage them regarding our solutions. Pharmaceutical Marketing team, helping them achieve their own

Bachelor’s degree with 10+ years of progressive pharmaceutical experience in marketing, or strategy, including exposure to both U.

The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the global value evidence strategy across the company's portfolio.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.I further attest that all information I submit in my employ

The VP, Pharmaceutical Quality is the functional head of product quality for the company, overseeing quality assurance and quality control, and managing the total cGMP compliance function. Strong cGMP knowledge in the pharmaceutical industry and implementing a phase-appropriate cGMP quality system.

Serve as the strategic partner and advisor to the SVP, Head of Pharmaceutical Sciences, driving execution of the organization's priorities. Advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline (PhD, MS, or equivalent required). CMC product

The Vice President Pharmaceutical Trade Relations oversees the development of Primes pharmaceutical relations strategy and manages Primes corporate relationship with pharmaceutical drug manufacturers. PBM), pharmaceutical drug distribution, procurement, contracting, business development, or other re

Demonstrates intimate level abilities and/or a proven record of success in the following areas: Pharmaceutical, Medical Devices, Diagnostics industries; End-to-end supply chain / network strategy and transformation; Supply chain analytics, supply chain technologies (strategy, master date mgmt. Demon

Allied Universal is currently hiring full and part time security officers for a pharma company in Boston, MA.All shifts and positions available including overnights and weekends.Ideal candidate has previous customer service experience and is comfortable with computers.Allied Universal is hiring a se

Job Summary The Assistant General Counsel – Pharmaceutical Distribution will be responsible for providing exceptional legal advice and guidance to the Pharmaceutical Distribution and Specialty Pharmaceutical Distribution segment business clients. Demonstrate knowledge of general commercial and hea

A leading pharmaceutical company seeks a Medical Director for Rare Disease to shape strategic processes and manage an emerging portfolio. Candidates must have an advanced scientific degree, 5+ years in the pharmaceutical industry, and experience in Clinical Development.

Knowledge of current industry trends and emerging technologies within the R&D Pharmaceutical and Pharmaceutical Sciences sectors.

Extensive experience in manufacturing lifecycle management, including process development, scale-up, and technology transfer in support of IND, clinical and/or commercial activities in the biotech or pharmaceutical industry. This individual is accountable for leading the Process Development function

Advanced level understanding of research and the pharmaceutical industry. Master’s degree required (preferably PhD), preferably in a health sciences related field with 10 years of research related experience and/or pharmaceutical industry experience.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. See Takeda Pharmaceutical Terms of Use at .

Candidates should have 6+ years in pharmaceutical quality, specifically in supplier quality, along with a strong knowledge of GMP regulations. A leading pharmaceutical company in Boston is seeking an Associate Director of Global Supplier Quality. This role involves executing supplier quality audits