4 Catalent Pharma Solutions jobs in Somerset
Senior Corporate Counsel, Drug Development
Posted today
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Job Description
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Summary:**
The Senior Corporate Counsel, DD Law role will have the opportunity to join the dynamic DD Law team at BMS. The DD Law team provides critical support and partnership to the global Drug Development organization, helping to deliver on our mission to develop and deliver more medicines to more patients faster. This individual will join an expert team of global Drug Development lawyers and will be charged with serving as a substantive leader for complex escalations and advising on novel approaches to accelerate development.
This individual should bring pharmaceutical legal experience with the ability to learn quickly, exercise excellent judgement, navigate complexity and be able to work with urgency and creativity across time zones, regulatory regimes, and senior stakeholders to advise on the successful resolution of legal and business issues and enable speed of getting medicines to patients who cannot wait. Excellent legal judgement and the ability to clearly communicate on complex topics with senior business stakeholders is critical to success in this role.
**Responsibilities:**
+ Serve as the lead legal advisor to Senior Vice Presidents reporting into the Executive Vice President, Head of Drug Development, and join their senior leadership teams, advising on complex issues that arise during the course of global drug development. Potential business clients to be supported include, SVP, Head of Global Development Operations, SVP Head of Global Regulatory Sciences, and SVP Head of Worldwide Patient Safety.
+ Collaborate with Drug Development legal team to develop and advance innovative approaches to accelerate drug development transactions, including automation.
+ Advise senior leaders on Drug Development initiatives that evolve internal and external stakeholder ways of working and improve the speed, accuracy and quality of drug development and ultimately speed of life-saving medacines to patients.
+ Work closely with Law Department colleagues to bring seamless legal support to Drug Development and provide DD legal guidance across the Law Department.
**Qualifications:**
+ Legal degree with 12 or more years of pharmaceutical legal experience. Helpful experience includes law firm, in-house and/ or government work experience. Experience working in the R&D space is helpful, but not required.
+ Demonstrated ability to develop strong relationships with colleagues and advise and influence senior executives, including SVP or C-suite stakeholders, on high-impact legal and regulatory matters.
+ Proven history of identifying and leading senior stakeholders and colleagues to implement innovative solutions to reduce waste, increase efficiency and improve management of legal risks.
+ Demonstrated ability to lead across large, global matrix organizations and influence senior leaders and colleagues across multiple functions to efficiently resolve complex issues.
+ Ability to independently prioritize and manage multiple projects.
+ Flexibility to work with speed and quality on a broad range of matters.
+ Ability to communicate complex issues clearly and concisely, verbally and in writing to senior leaders.
+ Excellent judgement, time management, and cross functional collaboration skills required.
+ Licensed to practice in the U.S.
#LIHybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Compensation Overview:**
Princeton - NJ - US: $255,260 - $309,309
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :05:56.553 UTC
**Location:** Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Automation Tech Lead (Pharmaceutical or Biopharmaceutical Industry)
Posted 7 days ago
Job Viewed
Job Description
**In this role, you will:**
· Own technical leadership across the automation project
· Act as the primary automation representative in cross-functional program leadership meetings, ensuring alignment between automation, process engineering, digital/MES, and quality teams
· Serve as the key point of contact for client stakeholders and senior leadership regarding automation scope, progress, and risk mitigation
· Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards
· Provide technical leadership to the multiple area leads working on their project for the respective area/node and ensure that applicable standards are followed
· Collaborate with project managers to define automation budgets, resource needs, and vendor engagement strategies.
· Ensure consistency of the automation deliverables (requirements, functional specifications, control strategies, phases, and recipes, etc.)
· Participate in P&ID and lead control strategy design
· Lead in defining the software components that need to be created or modified
· Communicates progress, issues, and needs to automation project manager for the entire workstream/all areas of the project
· Lead input, review, and approve of functional requirements and specifications
· Lead design of Parameter and Recipe Specification philosophy
· Respond to system integrator technical queries and provide design guidance.
· Lead and collaborate on the development of software testing strategies
· Identification of any remediation effort required on process control software
· Identify and analyze risks of technical nature particular to the area and planning responses
· Lead review and approval of functional specifications, control strategies, and software components.
· Collaborate with integrators on software testing and validation plans.
· Ensure integrator compliance with technical standards and program architecture.
· Provide technical leadership during Factory Acceptance Testing and commissioning.
· Maintain compliance with training requirements
· Provide training and support to junior engineers and other team members.
· Champion the adoption of emerging technologies, tools, and methodologies that improve automation efficiency, reliability, and maintainability.
We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a remote position open to qualified applicants in the United States. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs.
The working arrangements for this role are accurate as of the date of posting. This may change based on the project you're engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.
**What you need to have to be considered**
· 10+ years of hands-on automation experience within the pharmaceutical or biopharmaceutical industry-preferably in API/bulk manufacturing, monoclonal antibody, or bioconjugate environments.
· Proven expertise in leading Process Automation projects using the DeltaV platform, including architecture design, system configuration, testing, and deployment.
· Deep familiarity and demonstrated ownership of full Software Development Life Cycle (SDLC) and Agile methodologies in automation projects.
· Strong understanding of ISA-88 batch control standards and GAMP guidelines.
· Clear understanding of automation compliance requirements, including GMP and validation principles.
· Demonstrated ability to lead cross-functional teams, mentor engineers, and drive technical decision-making.
· Excellent communication skills with the ability to collaborate across engineering, quality, and digital/MES teams and with the ability to influence stakeholders at all levels.
· Ability to manage multiple priorities and stakeholders in a dynamic project environment.
· Experience with SCADA, PLCs, HMI, APIs, SQL software and other OT systems is not required but desirable.
We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.
**Salary and Other Compensation** :
Applications will be accepted until October 9 th , 2025.
The annual salary for this position is between $100,000 - $153,000 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
· Medical/Dental/Vision/Life Insurance
· Paid holidays plus Paid Time Off
· 401(k) plan and contributions
· Long-term/Short-term Disability
· Paid Parental Leave
· Employee Stock Purchase Plan
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
SD/AVP pf Biologics Drug Product Development - (Princeton)
Posted 1 day ago
Job Viewed
Job Description
Strategic Leadership
Technical Excellence in Complex Molecules
- ADC ADC Drug Product Development
- Multi-Domain Molecules
- Novel Modalities
Advanced Lyophilization Development
High-Concentration Formulation Expertise
>150 mg/mL
Team Leadership & Development
CMC Global CMC Integration
Technology Innovation
CMC CMC Regulatory Strategy
Educational Background
Relevant Experience
- 15 8
- ADCs
- FDA EMA
- ADC
Job Responsibilities
Location: Suzhou/ Guangzhou/ Lianyungang
1. Strategic Leadership
Define and implement the overall drug product development strategy with specialized focus on complex molecules (bispecifics, ADCs, fusion proteins), advanced lyophilization platforms, and high-concentration formulation technologies.
2. Technical Excellence in Complex Molecules
Provide expert guidance in addressing unique challenges of complex biologics, including:
- ADC Drug Product Development : Overcoming challenges related to payload solubility, surfactant optimization, and conjugation stability.
- Multi-Domain Molecules : Developing strategies to address aggregation, fragmentation, and viscosity issues in bispecifics and fusion proteins.
- Novel Modalities : Establishing platform approaches for emerging biologic formats while developing molecule-specific solutions.
3. Advanced Lyophilization Development
Lead the development of sophisticated lyophilization strategies for complex molecules:
- Design and optimize lyophilization cycles for challenging molecules with narrow collapse margins.
- Develop platform approaches for rapid lyophilization cycle development.
- Implement advanced characterization techniques (e.g., freeze-dry microscopy, manometric temperature measurement) for cycle optimization.
4. High-Concentration Formulation Expertise
Drive the development of high-concentration formulations (>150 mg/mL) for subcutaneous delivery:
- Develop strategies to mitigate high viscosity challenges through excipient optimization and innovative formulation approaches.
- Address stability challenges associated with high protein concentrations.
- Optimize formulations for compatibility with auto-injectors and other delivery devices.
5. Team Leadership & Development
Build, mentor, and lead a high-performing team of scientists and engineers specializing in complex molecule drug product development.
6. Global CMC Integration
Serve as the drug product subject matter expert for complex molecules, collaborating with Process Development, Analytical Development, and Regulatory Affairs to define and implement advanced control strategies.
7. Technology Innovation
Champion the implementation of cutting-edge technologies including computational modeling, advanced analytics, and continuous manufacturing approaches for drug product development.
8. CMC Regulatory Strategy
Lead the preparation and defense of drug product sections in global regulatory submissions, with particular expertise in justifying complex formulation and process decisions to health authorities.
Qualifications
1. Educational Background
- Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field.
- Candidates with study experience at well-known overseas universities/institutions are preferred.
2. Relevant Experience
- Minimum of 15+ years of direct experience in biologics drug product development, with at least 8+ years in leadership roles managing scientists and engineers.
- Extensive hands-on experience with complex molecules including ADCs, bispecific antibodies, and fusion proteins is mandatory.
- Proven track record in developing and commercializing lyophilized products and high-concentration formulations for biologics.
- Experience with global regulatory submissions (US FDA, EMA) for complex biologics is essential.
Competency Requirements
- Deep technical expertise in:
- Lyophilization cycle development and scale-up for complex molecules
- High-concentration formulation development and viscosity mitigation strategies
- ADC drug product development and conjugation stability optimization
- Primary packaging and delivery system compatibility for complex formulations
- Strong publication and patent record in advanced drug product technologies is highly desirable.
- Demonstrated success in building and leading high-performing technical teams.
- Excellent strategic planning and cross-functional collaboration skills.
SD/AVP pf Biologics Drug Product Development — 恒瑞-全球精英计划
Posted today
Job Viewed
Job Description
工作职责
位置：苏州、广州、连云港
一、战略制定（Strategic Leadership）
制定并实施整体制剂开发战略，重点关注复杂分子（双特异性抗体、抗体药物偶联物、融合蛋白）、先进冻干平台及高浓度制剂技术。
二、复杂分子技术专长（Technical Excellence in Complex Molecules）
为解决复杂生物药的独特挑战提供专业指导，包括：
- ADC 制剂开发（ADC Drug Product Development） ：解决载荷溶解度、表面活性剂优化及偶联稳定性的技术挑战。
- 多结构域分子（Multi-Domain Molecules） ：制定策略以解决双特异性抗体及融合蛋白的聚集、断裂及粘度问题。
- 新型制剂（Novel Modalities） ：为新兴生物药建立平台方法，同时开发分子特异性解决方案。
三、冻干制剂开发（Advanced Lyophilization Development）
主导针对复杂分子的精密冻干策略开发：
- 为塌陷温度窗口狭窄的挑战性分子设计和优化冻干周期。
- 开发快速冻干周期建立的平台方法。
- 采用先进表征技术（如冷冻干燥显微镜、压力温度测量）进行周期优化。
四、高浓度制剂开发（High-Concentration Formulation Expertise）
推动用于皮下注射的高浓度制剂（>150 mg/mL）开发：
- 通过辅料优化和创新制剂策略解决高粘度挑战。
- 解决高蛋白质浓度相关的稳定性挑战。
- 优化制剂以适配自动注射器及其他给药装置。
五、团队领导与发展（Team Leadership & Development）
负责搭建、培养并领导一支专注于复杂分子制剂开发的高效团队（成员含科学家与工程师）。
六、全球 CMC 统筹（Global CMC Integration）
担任复杂分子的制剂领域专家，与工艺开发、分析开发及监管事务团队协作，制定并实施先进控制策略。
七、技术创新（Technology Innovation）
倡导采用尖端技术，包括计算建模、先进分析技术及连续生产方法，应用于制剂开发。
八、CMC 监管战略（CMC Regulatory Strategy）
主导全球监管申报中制剂部分的准备与答辩工作，尤其需具备向监管机构论证复杂制剂及工艺决策合理性的专业能力。
任职资格
一、教育背景（Educational Background）
- 药剂学、制药科学、生物化学、化学工程或相关专业博士学位。
- 具有海外知名院校留学背景者优先。
二、相关经验（Relevant Experience）
- 15 年以上生物药制剂开发直接工作经验，其中至少 8 年担任领导岗位，管理科学家与工程师团队。
- 必须具备丰富的复杂分子实操经验，包括抗体药物偶联物（ADCs）、双特异性抗体及融合蛋白。
- 拥有生物药冻干产品及高浓度制剂开发与商业化的经证实业绩记录。
- 具备复杂生物药全球监管申报（美国 FDA、欧洲 EMA）经验。
能力要求
- 深厚技术储备 ，包括：
- 复杂分子的冻干周期开发与放大
- 高浓度制剂开发及粘度降低策略
- 抗体药物偶联物（ADC）制剂开发及偶联稳定性优化
- 复杂制剂的原包装及给药装置兼容性研究
- 在先进制剂技术领域有丰富发表成果及专利记录者优先。
- 具备搭建并领导高效技术团队的经验。
- 具备出色的战略规划及跨职能协作能力。
Job Responsibilities
Location: Suzhou/ Guangzhou/ Lianyungang
1. Strategic Leadership
Define and implement the overall drug product development strategy with specialized focus on complex molecules (bispecifics, ADCs, fusion proteins), advanced lyophilization platforms, and high-concentration formulation technologies.
2. Technical Excellence in Complex Molecules
Provide expert guidance in addressing unique challenges of complex biologics, including:
- ADC Drug Product Development : Overcoming challenges related to payload solubility, surfactant optimization, and conjugation stability.
- Multi-Domain Molecules : Developing strategies to address aggregation, fragmentation, and viscosity issues in bispecifics and fusion proteins.
- Novel Modalities : Establishing platform approaches for emerging biologic formats while developing molecule-specific solutions.
3. Advanced Lyophilization Development
Lead the development of sophisticated lyophilization strategies for complex molecules:
- Design and optimize lyophilization cycles for challenging molecules with narrow collapse margins.
- Develop platform approaches for rapid lyophilization cycle development.
- Implement advanced characterization techniques (e.g., freeze-dry microscopy, manometric temperature measurement) for cycle optimization.
4. High-Concentration Formulation Expertise
Drive the development of high-concentration formulations (>150 mg/mL) for subcutaneous delivery:
- Develop strategies to mitigate high viscosity challenges through excipient optimization and innovative formulation approaches.
- Address stability challenges associated with high protein concentrations.
- Optimize formulations for compatibility with auto-injectors and other delivery devices.
5. Team Leadership & Development
Build, mentor, and lead a high-performing team of scientists and engineers specializing in complex molecule drug product development.
6. Global CMC Integration
Serve as the drug product subject matter expert for complex molecules, collaborating with Process Development, Analytical Development, and Regulatory Affairs to define and implement advanced control strategies.
7. Technology Innovation
Champion the implementation of cutting-edge technologies including computational modeling, advanced analytics, and continuous manufacturing approaches for drug product development.
8. CMC Regulatory Strategy
Lead the preparation and defense of drug product sections in global regulatory submissions, with particular expertise in justifying complex formulation and process decisions to health authorities.
Qualifications
1. Educational Background
- Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field.
- Candidates with study experience at well-known overseas universities/institutions are preferred.
2. Relevant Experience
- Minimum of 15+ years of direct experience in biologics drug product development, with at least 8+ years in leadership roles managing scientists and engineers.
- Extensive hands-on experience with complex molecules including ADCs, bispecific antibodies, and fusion proteins is mandatory.
- Proven track record in developing and commercializing lyophilized products and high-concentration formulations for biologics.
- Experience with global regulatory submissions (US FDA, EMA) for complex biologics is essential.
Competency Requirements
- Deep technical expertise in:
- Lyophilization cycle development and scale-up for complex molecules
- High-concentration formulation development and viscosity mitigation strategies
- ADC drug product development and conjugation stability optimization
- Primary packaging and delivery system compatibility for complex formulations
- Strong publication and patent record in advanced drug product technologies is highly desirable.
- Demonstrated success in building and leading high-performing technical teams.
- Excellent strategic planning and cross-functional collaboration skills.
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