Development Scientist jobs at Catalent Pharma Solutions - 772 jobs

The role will be responsible for all operations involved with routine manufacturing and quality control testing of radiopharmaceuticals produced in Aktis' GMP laboratory (Boston, MA), including but not limited to the list below. This role will report to the Director of Clinical Trial Manufacturing. Salary Range: $136,800.00 To $189,200.00 Annually Responsibilities Manual and automated production of radiopharmaceuticals in a GMP facility QC testing of radiopharmaceuticals Execution and upkeep of the facilities' environmental monitoring program Accurate and timely preparation and completion of manufacturing and Quality control records (Batch Records, Forms, Logbooks, etc.) Process/analytical method validation for clinical manufacturing Operation and maintenance of equipment in the GMP facility Preparation of products for shipment to other sites Drafting, reviewing and updating GMP documentation including SOPs Upkeep and maintenance of inventory in the GMP Facility Maintenance of the GMP facility including assisting with radioactive waste stream management Perform contamination wipe tests and surveys Performing and maintenance of the facilities' environmental monitoring program Leading manufacturing process and analytical method qualification activities Contribute to writing CMC sections for submission to regulatory agencies Maintain KPI and internal reports Supporting external tech transfer activities Required Skills Proficient with aseptic operations and environmental monitoring Proficient with QC methodologies (HPLC, GC, MS, Gamma Spec, etc.) Proficient with assembly and interpretation of analytical data Expertise with troubleshooting analytical and production equipment High attention to detail and organizational skills to enable working in a fast-paced environment Ability to work in an ISO7 environment with full gowning Adhere to stringent cleanroom protocols and maintain a high level of hygiene Perform precise aseptic manipulations in a restrictive environment Awareness of FDA and EU GMP requirements Ability to lift 60lbs Expertise with GMP radiopharmaceutical manufacturing and quality control Minimum, B.Sc. with 10+ years or M.Sc. with 7+ years of experience in the pharma industry or equivalent research experience Comprehensive knowledge of GMP manufacturing and quality control workflows Excellent verbal, written, and organizational skills Strong desire to be part of a mission‐oriented company leading transformative change for patients Proven demonstration of transparent communication and fostering open and diverse debate Ability to work with agility and manage ambiguity Personifies positive energy and exemplifies respect #J-18808-Ljbffr

A leading global healthcare firm in San Diego is seeking a highly motivated scientist to contribute to biotherapeutics development. The successful candidate will discover and engineer antibodies, oversee experiments, and utilize various molecular biology techniques. Applicants should have at least 6 years of relevant experience and a strong background in flow cytometry. This position offers competitive compensation ranging from $110,250 to $187,000 along with comprehensive benefits. #J-18808-Ljbffr

A global healthcare leader in San Diego seeks a highly motivated scientist to contribute to the discovery and development of biotherapeutics. The role involves discovering and optimizing antibodies, utilizing flow cytometry, and requires strong skills in molecular biology and biochemistry. Ideal candidates should have significant industry experience and be detail-oriented, with excellent communication skills. Competitive compensation and benefits include a flexible benefits package and bonus potential. #J-18808-Ljbffr

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role Kerry is seeking a Research, Development and Application Senior Scientist for a key role supporting the growth of the North American Beverage market. This position is based at the KERRY Global Technology & Innovation Centre in Beloit, Wisconsin, USA, reporting to the RD&A Director/Manager and is responsible for executing on the business strategy by creating market relevant and differentiated products that meet the requirements of customers and consumers, utilizing Kerry's broad and industry leading portfolio of technologies. This role is part of a team of RD&A Scientists and Technicians that are responsible for the development of powder and liquid beverage concepts. Strong communication and leadership skills are critical as the day-to-day activities involve significant cross-functional collaboration with Flavorists, Nutrition Scientists, Regulatory, Marketing, Sales, and Finance. Key responsibilities Lead formulation and concept development from end-to-end on internal and customer projects within North America for the Beverage market. Use sound commercial and technical awareness of ingredients, processes, end use market and customer requirements to deliver on project objectives, across powder beverages and liquid beverage product formats. Develop innovative solutions to help grow customers and Kerry's market share within cost parameters and manufacturing capabilities while ensuring all new products are legal within country of use. Manage Pilot Plant validation work and facilitate first production trials of new products internally and with third part manufacturers. Build strong relationships with customer contacts via clear communication, on-site and virtual visits, presentations and supporting trials when required. Support sales and business representatives during customer calls through technical presentations and product demonstrations. Work within cross-functional teams to optimize the strengths of Kerry and deliver the best Taste and Nutrition experience for our customers. Study methods to improve quality of products such as flavour, colour, texture, nutritional value, as well as physical, chemical, and microbiological composition. Qualifications and skills BSc/MSc/PhD in Food Science, Food Engineering, or related field. 5+ years of hands-on experience in product development, preferably beverages products. Experience working with 'functional ingredients' is a plus - probiotics, adaptogens, botanical extracts, etc. Working knowledge of the beverage market in North America. Proven success in product development resulting in successful market launch. Curiosity and a willingness to push creative boundaries. Strong team-player, with excellent interpersonal, organizational, communication and project management skills. Knowledgeable about food chemistry, sensory, microbiology, food packaging systems and food engineering. The pay range for this position is 75,602- 123,432 in Annual Salary. Kerry typically does not hire an individual at the top or near the top of the range, as we are a pay-for-performance company, and this range is set to continue to reward performance annually while in role. Compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate within the above range may be influenced by a variety of factors including skills, qualifications, experience, and internal equity. Kerry offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, Employee Share Plan, Life, disability, and accident insurance, and tuition reimbursement. This job posting is anticipated to expire on Dec 27, 2025. Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov). Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role This role encompasses leading a descriptive sensory panel and maintaining an end-use market as a sensory lead. The position requires strong leadership, technical expertise in sensory science, and the ability to collaborate cross-functionally to support business objectives through high-quality sensory insights. Key responsibilities • Lead and manage a trained sensory panel of 8-16 individuals using the Spectrum Descriptive Analysis (SDA) method. • Develop and implement project-specific training and calibration plans. • Facilitate training, calibration, and testing sessions in compliance with SDA methodology. • Define and maintain reference materials for all attributes of interest. • Monitor and evaluate panel performance; address underperformance through retraining and recalibration. • Maintain panel size through recruitment, screening, and fit-for-purpose assessments. Sensory Testing & Methodology • Design and execute sensory testing using SDA, temporal, and discrimination methods. • Analyze data using relevant sensory software and interpret panel performance metrics. • Communicate findings to sensory leads and project stakeholders. Project Collaboration & Execution • Meet with stakeholders to understand business objectives and define sensory goals. • Collaborate with sensory project leads to select appropriate methodologies and testing logistics. • Coordinate with technicians and technologists to ensure timely preparation of test materials and references. Strategic Sensory Leadership • Act as the sensory lead for an end-use market, maintaining a pipeline of internal and customer-facing projects. • Design, organize, and execute sensory studies aligned with business objectives. • Analyze and interpret test results, providing actionable insights and next steps. • Stay current with sensory science developments and adopt new techniques to enhance capabilities. Qualifications and skills Skills & Competencies: • Expertise in sensory science, particularly descriptive analysis and SDA methodology. • Strong leadership and team management skills. • Proficiency in sensory data analysis tools and statistical interpretation. • Excellent communication skills for both technical and non-technical audiences. • Ability to collaborate across functions including R&D, marketing, and business development. Experience & Qualifications: • Bachelor's, Master's, or PhD in Food Science, Sensory Science, or a related field. • Prior experience leading and managing sensory panels is essential. • Experience with Spectrum Descriptive Analysis is highly preferred. • Familiarity with temporal and discrimination testing methods. • Occasional travel (approximately once a month) may be required for customer visits or panel-related activities. The typical hiring range for this role is $75,602 to $123,432 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role We are seeking a passionate and technically skilled Dairy Scientist to join our R&D team. In this role, you will leverage your expertise in dairy science, food technology, microbiology or related fields to develop, optimize, and support innovative dairy products and solutions. You will collaborate closely with cross-functional teams-including product development, process engineering, and commercial teams-to deliver high-quality, market-leading dairy flavors. Key responsibilities Develop and optimize flavor formulations for a variety of dairy products (e.g., yogurt, cheese, beverages, desserts) through the use of cultures, enzymes, materials and processes. Lead application trials and pilot plant runs to validate new concepts and processes. Collaborate with customers and internal teams to understand requirements and deliver tailored solutions. Troubleshoot formulation and processing challenges, providing technical support to both internal stakeholders and customers. Stay current with industry trends, new ingredients, and processing technologies relevant to dairy applications. Document and communicate findings, protocols, and recommendations clearly and effectively. Support commercialization efforts by scaling up successful prototypes and assisting with plant trials. Ensure all work complies with food safety, quality, and regulatory standards. Qualifications and skills Bachelor's or Master's degree in Food Science, Dairy Science, Chemical Engineering, Microbiology or a related field. 3+ years of experience in dairy product development or applications (internships and co-ops considered). Strong knowledge of dairy ingredients, processing technologies, and product functionality. Hands-on experience with pilot plant equipment and laboratory analysis. Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Ability to manage multiple projects and adapt to changing priorities. Willingness to travel as needed (up to 20%)} Experience working directly with customers or in a B2B environment. Familiarity with regulatory requirements for dairy products. The typical hiring range for this role is $91,311 to $149,080 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov). Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview Perrig is currently hiring for an Associate R&D Process Scientist to lead scale-up of new infant formulas from development to full-scale production, overseeing change control, risk assessment, and factory trials while collaborating with cross-functional teams including Product Development, Pilot Plant, Operations, Quality, and Planning. Support manufacturing sites on continuous improvement opportunities in recipe and processing, driving optimization and renovation initiatives through root-cause analysis, cross-functional collaboration, and execution of cost-reduction strategies while ensuring compliance and operational excellence. Develop and implement new process capabilities via feasibility trials and continuous improvement projects to enhance efficiency, reduce costs, and improve overall product quality. Scope of the Role * Realize scale up / industrialization with Manufacturing and Quality departments. Manage change controls - review BOMs/formulations, host risk assessment meetings, setting up manufacturing forms or info, update block flow diagrams, review finished product nutrient data, recipe / process parameterization, support regulatory filings, etc * Support new process evaluations or co-man/pack capabilities or CAPEX projects for new equipments for Perrigo Nutrition business * Support manufacturing sites including root-cause analysis to address identified losses, optimize manufacturing / product quality issues, and support resolve of unscheduled downtime Experience Required * Bachelor's degree in Food or Dairy Science, Chemical or Food Engineering, Chemistry or closely related field preferred. * 1-3 years of experience in product and/or process development in the food industry or closely related is strongly preferred. * Experience in common food and dairy unit operations, infant formula manufacturing and knowledge of spray drying a plus. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo Nearest Major Market: Eau Claire

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. In this role, the candidate will coordinate multi-functional initiatives in the research, creation, and implementation of scientific studies. These studies facilitate developability evaluation of biotherapeutic drug candidates. The candidate will also formulate drug products (DP), perform characterization, and validate commercial parenteral/injectable biologic products. The candidate will lead the development of drug candidates and utilization of in-silico tools in support of developability, pre-candidate selection and formulation and process development. An understanding of protein chemistry, protein engineering, formulation development as well as the ability to run computer simulations or biopharmaceutical assays in a laboratory is necessary. The candidate will establish continuous improvement systems based on lessons learned and implement these improvements in areas of developability assessment, drug formulations, manufacturing technology transfer activities as well as in-silico process simulations. This position is encouraged to interact regularly with multi-functional staff from Research, Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs. Key Responsibilities: Leads drug product development teams with multiple multi-functional collaborators, as well as understand the multi-functional implication of project activities and decisions on project and corporate objectives. Makes scientific/technical proposals based on corporate or project objectives. The candidate must have the ability to communicate effectively with senior management, external partners, and/or regulatory agencies. Actively participates in department and team meetings including assuming ownership and delivering on assign action items. Understands "big pictures" for projects and tasks involved and prioritize work of self and others accordingly. Prioritizes multiple work you're doing and projects and leads project teams consisting of one or more junior team members. The ability to work independently as well as part of the team is essential. Perform in-depth data analysis. Write technical reports and sections of clinical and commercial regulatory filings. These documents cover accomplished studies for Alexion drug product candidates. Be current with the literature about drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations Essential Education, Experience & Skills: PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 0-2 years, a MS with 9+ years or BS with 10+ years of relevant experience. Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred. Scientific and practical knowledge of protein biochemistry, protein formulation/stability, protein engineering or protein purification as well as biopharmaceutical development is essential. Hands-on experience with developing and utilizing computational tools for protein engineering, protein solution behavior prediction, manufacturing process design and scale-up or automation Experience in biotherapeutics development as well as understanding of the biotechnology products life cycle Understanding of the biotherapeutics engineering, drug development and analytical or in-silico tools used to test drug candidates or processes is desirable. Makes strategic scientific/technical proposals based upon corporate or project objectives and has the ability to take initiative in problem solving and finding solutions to scientific challenges. The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential. Excellent interpersonal skills are required, as is the strong ability to communicate effectively, as well as mentor and motivate others within the department and as part of actively participating in cross-functional teams. The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging Desired Experience & Skills: Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage. Experience with in-silico tools such as GROMACS, NAMD, BioLuminate, MOE, Python ML libraries, gPROMs or related tools Experience with programming languages such as Python, C++, Fortran, R or related languages Knowledgeable in Global Regulatory guidances, cGMPs, and Quality/Compliance expectations for the development of parenteral drugs The annual base pay (or hourly rate of compensation) for this position ranges from $110,687 to $145,277. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. #LI-Hybrid FUSION Date Posted 14-Jan-2026 Closing Date 13-Feb-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Interpret complex datasets and translate findings into formulation composition, technical reports, process parameters, control strategies, and regulatory filings. Interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Device Development, Manufacturing Technical Services, Quality Assurance, and CMC Regulatory Affairs. You will be responsible for: Leading phase appropriate formulation and process development for injectable biologics, translating program goals into experimental plans, decision criteria, timelines, and risk mitigation from candidate selection through commercial validation and filings. Designing, executing, and troubleshooting laboratory studies using advanced biophysical and analytical methods, with hands on responsibility for high quality data generation. Defining and optimizing drug product processes (fill/finish relevant unit operations, viscosity management, filtration, mixing, hold steps), conducting scaleup and robustness studies, and supporting technology transfer to internal and external manufacturing sites. Integrating complex datasets to establish structure-function relationships, degradation pathways, and mechanism informed stress models; translating insights into robust formulations, control strategies, and phase appropriate specifications. Authoring protocols, technical reports, and contributing to CMC sections of regulatory submissions, including comparability assessments and responses to regulatory queries. Cross functional collaboration with to align development plans and ensure timely program delivery. Mentoring junior team members in matrix teams; reviewing study designs and data; promoting experimental rigor and documentation excellence. Work with senior management, partners, and cross functional teams; presenting program status, risks, and recommendations; taking initiative to solve scientific and operational challenges. You will need to have: PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 5 years of proven experience MS with 14 years or BS with 15+ years of proven experience. Excellent interpersonal skills Ability to mentor and empower others within the team and cross-functionally. Scientific and practical knowledge of protein biochemistry, protein formulation, and stability. Make strategic scientific/technical proposals based upon corporate or project objectives and can take initiative in problem solving and finding solutions to scientific challenges. The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging We would prefer for you to have: Electronic record keeping and data software, (electronic lab notebooks, EndNote) Maintenance of laboratory instrumentation (prioritizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro. Knowledgeable in Global Regulatory guidance, cGMPs, and Quality/Compliance expectations for the development of parenterals. Validated background in protein chemistry, chemistry, biochemistry, or equivalent. Hands-on experience with process development, scale up, and tech transfer to manufacturing sites. Expertise in AUC Why AstraZeneca? When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca offers an environment where innovation thrives. Our commitment to eliminating cancer as a cause of death drives us to challenge the status quo and deliver more effective treatments. With access to industry-leading research, technology, and a pipeline like no other, you will be empowered to accelerate your career while making a meaningful impact on patients' lives. Our entrepreneurial spirit encourages you to step up, take accountability, and lead changes in our dynamic environment. Together, we are reshaping healthcare systems through collaboration, innovation, and advocacy. Ready to make a difference? Apply now and be part of our journey to redefine cancer treatment! Date Posted 12-Jan-2026 Closing Date 29-Apr-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Introduction to role Join our dynamic Waltham team within Biologics Engineering, where innovation meets dedication. As part of a global organization, we are committed to discovering and optimizing next-generation biologics across key therapeutic areas. Our mission is to push the boundaries of science and creativity, delivering life-changing medicines to patients. Are you ready to contribute to groundbreaking biologics discovery platforms and novel drug modalities that address unmet medical needs? Accountabilities As a Scientist in our Waltham, MA team, you will play a crucial role in executing well-validated SOPs for high-throughput antibody production and purification. Your focus will be on delivering microgram-to-milligram quantities of antibody therapeutics efficiently and reliably. You will manage scheduled production campaigns, ensure instrumentation readiness, perform routine QC, and compile comprehensive data packages for project teams. Essential Skills/Experience Master's degree with 1+ years of experience in antibody expression/purification, UPLC, or molecular biology Bachelor's degree with 3+ years of experience in antibody expression/purification, UPLC, or molecular biology Demonstrated experience executing standardized high-throughput expression and purification workflows for antibodies or antibody-like proteins at microgram-to-milligram scale. Hands-on operation of liquid handlers (Hamilton or Lynx preferred) using validated methods with integrated automation platforms (Biosero/Green Button Go) a plus. Proficiency in mammalian cell culture (CHO and HEK293), aseptic technique, and transient expression. Experience with sample tracking and laboratory logistics/LIMS software; comfort with barcode-driven workflows. Ability to plan production runs, manage consumables, and meet deadlines in a fast-paced environment. Strong attention to detail, documentation rigor, and adherence to SOPs and QC acceptance criteria. Effective communication and collaboration across cross-functional teams. Desirable Skills/Experience Working knowledge of protein purification technologies and common analytical methods (e.g., SEC-UPLC, LC-MS, SDS-PAGE, CE). Familiarity with lab automation scheduling software; Green Button Go preferred. Basic scripting for data handling (e.g., Python, Jupyter) is a plus, not required. Exposure to imaging or flow cytometry platforms and analysis tools (iQue, Attune, FlowJo) is beneficial for specific assays but not central to the role. AstraZeneca offers an inspiring environment where you can apply your expertise in new ways. We thrive on change and embrace the unknowns, taking calculated risks to deliver new medicines to patients. Our collaborative approach encourages learning from diverse minds, pushing boundaries to find innovative solutions. Here, every challenge is an opportunity for growth, supported by leaders who empower you to make a tangible difference in society. Why AstraZeneca? At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. You'll be part of a globally connected team working at the forefront of innovation-driving advances that impact patients around the world. With a strong emphasis on collaboration, continuous improvement, and scientific excellence, this is your opportunity to lead a team that makes a real difference. Diversity and Inclusion at AstraZeneca We believe that diversity drives innovation. AstraZeneca is committed to building an inclusive culture that celebrates diverse perspectives and fosters belonging. We welcome all qualified applicants and ensure compliance with applicable laws regarding inclusivity and employment eligibility. Individuals with disabilities can request reasonable accommodations throughout the recruitment process. Ready to make an impact? Apply now and join us in our mission to transform patient lives through scientific innovation! The annual base pay (or hourly rate of compensation) for this position ranges from $ 87,200 to $ 130,800. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans Date Posted 15-Jan-2026 Closing Date 20-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Type: Full Time Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA About the Job: Title of the Position: Senior Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry. Responsibilities: Lead the design, development, and optimization of complex injectable and sterile dosage forms. Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA). Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives. Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs. Define scope, timeline, and resource needs of functional activities and keep team on schedule Participate in evaluation of new product opportunities. Ensure timely and high-quality documentation for regulatory submissions. Stay updated with all FDA and regulatory requirements/guidelines. Provide mentorship and leadership to team members. Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance. Author and review technical reports, protocols, and regulatory documents. Additional duties and assignments as needed. Qualifications: Education/Experience: Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.) Strong understanding of formulation principles, excipients, and drug delivery systems. Hands-on experience with various formulation techniques and equipment. Proven track record of successful formulation development and commercialization. Experience with statistical design of experiments (DOE) and data analysis. Knowledge, Skills, and Abilities: Proven track record of successful formulation development for various sterile dosage forms. Strong leadership, project management, and organizational skills. Expertise in complex injectable and sterile dosage form development. Demonstrated ability to conduct independent research and problem-solving. Requirements: Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius). Benefits: Pay range $70,000-$90,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Type: Full Time Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA About the Job: Title of the Position: Senior Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry. Responsibilities: Lead the design, development, and optimization of complex injectable and sterile dosage forms. Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA). Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives. Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs. Define scope, timeline, and resource needs of functional activities and keep team on schedule Participate in evaluation of new product opportunities. Ensure timely and high-quality documentation for regulatory submissions. Stay updated with all FDA and regulatory requirements/guidelines. Provide mentorship and leadership to team members. Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance. Author and review technical reports, protocols, and regulatory documents. Additional duties and assignments as needed. Qualifications: Education/Experience: Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.) Strong understanding of formulation principles, excipients, and drug delivery systems. Hands-on experience with various formulation techniques and equipment. Proven track record of successful formulation development and commercialization. Experience with statistical design of experiments (DOE) and data analysis. Knowledge, Skills, and Abilities: Proven track record of successful formulation development for various sterile dosage forms. Strong leadership, project management, and organizational skills. Expertise in complex injectable and sterile dosage form development. Demonstrated ability to conduct independent research and problem-solving. Requirements: Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius). Benefits: Pay range $70,000-$90,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job DescriptionDescription: We are seeking a Senior Formulation Scientist to join our dynamic R&D team, where you'll play a key role in developing innovative pharmaceutical and nutraceutical products. In this hands-on role, you'll design formulations, support process improvements, and contribute directly to product development from concept to commercialization. This position offers exposure to oral solid dosage forms. Candidates may specialize in drug formulation or nutraceutical formulation, with the opportunity to grow into broader product development responsibilities. Job Type: Full-Time Location: Hauppauge, NY Works Hours: Monday - Friday, 9:00AM - 5:00PM Pay Range: $85,000 - $125,000 per year, depending on experience Start Date: ASAP What makes this role exciting: Diverse formulation experience - work on nutraceuticals, OTC, and prescription oral solid dosage forms. Hands-on innovation - operate formulation equipment like blenders, high shear granulators, fluid bed dryers, and tablet presses. End-to-end impact - take ideas from early development through regulatory submission and commercialization. Collaborative environment - partner with R&D, production, and regulatory teams, contributing to problem-solving and process improvements. Why Join CPC? At CPC, you'll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact. Requirements: Responsibilities In this role, you will: Design and develop formulations for oral solid dosage forms across nutraceutical, OTC, and prescription products Manage multiple formulation projects and deliver results on time Write protocols, Master Manufacturing Records (MMRs), and product development reports Provide process improvement support and troubleshoot production issues Stay current with emerging trends in drug delivery technology and regulatory policies Education & Experience MS required; Ph.D. preferred Minimum 5 years of formulation experience in pharmaceutical and/or nutraceutical product development Hands-on experience with formulation equipment such as blenders, fluid bed dryers, high shear granulators, and tablet presses Skills, Knowledge & Abilities Knowledge of cGMPs, US FDA, and EU/EMEA regulatory requirements Familiarity with Quality System standards, ICH guidelines, USP, and EP requirements Experience preparing protocols, Master Manufacturing Records (MMRs), and product development reports Ability to troubleshoot formulation or process issues and recommend practical solutions Strong project management skills, able to prioritize and manage multiple development projects Effective oral and written communication; able to collaborate with R&D, production, and regulatory teams Detail-oriented, organized, and proactive with a strong problem-solving mindset Willingness to learn new technologies and adapt to evolving project needs Experience with regulatory submissions preferred for pharmaceutical candidates Exposure to multi-product development is preferred but not required

We are seeking a Senior Formulation Scientist to join our dynamic R&D team, where you'll play a key role in developing innovative pharmaceutical and nutraceutical products. In this hands-on role, you'll design formulations, support process improvements, and contribute directly to product development from concept to commercialization. This position offers exposure to oral solid dosage forms. Candidates may specialize in drug formulation or nutraceutical formulation, with the opportunity to grow into broader product development responsibilities. Job Type: Full-Time Location: Hauppauge, NY Works Hours: Monday - Friday, 9:00AM - 5:00PM Pay Range: $85,000 - $125,000 per year, depending on experience Start Date: ASAP What makes this role exciting: Diverse formulation experience - work on nutraceuticals, OTC, and prescription oral solid dosage forms. Hands-on innovation - operate formulation equipment like blenders, high shear granulators, fluid bed dryers, and tablet presses. End-to-end impact - take ideas from early development through regulatory submission and commercialization. Collaborative environment - partner with R&D, production, and regulatory teams, contributing to problem-solving and process improvements. Why Join CPC? At CPC, you'll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact. Requirements Responsibilities In this role, you will: Design and develop formulations for oral solid dosage forms across nutraceutical, OTC, and prescription products Manage multiple formulation projects and deliver results on time Write protocols, Master Manufacturing Records (MMRs), and product development reports Provide process improvement support and troubleshoot production issues Stay current with emerging trends in drug delivery technology and regulatory policies Education & Experience MS required; Ph.D. preferred Minimum 5 years of formulation experience in pharmaceutical and/or nutraceutical product development Hands-on experience with formulation equipment such as blenders, fluid bed dryers, high shear granulators, and tablet presses Skills, Knowledge & Abilities Knowledge of cGMPs, US FDA, and EU/EMEA regulatory requirements Familiarity with Quality System standards, ICH guidelines, USP, and EP requirements Experience preparing protocols, Master Manufacturing Records (MMRs), and product development reports Ability to troubleshoot formulation or process issues and recommend practical solutions Strong project management skills, able to prioritize and manage multiple development projects Effective oral and written communication; able to collaborate with R&D, production, and regulatory teams Detail-oriented, organized, and proactive with a strong problem-solving mindset Willingness to learn new technologies and adapt to evolving project needs Experience with regulatory submissions preferred for pharmaceutical candidates Exposure to multi-product development is preferred but not required

Job DescriptionScientist, Biologics Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Responsibilities: Primary responsibilities include, but are not limited to the following: Perform analytical and biological sample testing • Conduct method development and validation studies • Perform immunoassay techniques: (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies), with proficiency • Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays • Maintenance of instruments, and address technical and instrumental issues • Assist the Principal Investigator with study conduct • Maintain study documentation • Meet regulatory compliance requirements • Maintain a safe work environment Requirements: Bachelor's degree in related scientific discipline or Bachelors degree with relevant experience • At least 2 years working in a laboratory preferred Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Scientist, Biologics Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Responsibilities: Primary responsibilities include, but are not limited to the following: Perform analytical and biological sample testing • Conduct method development and validation studies • Perform immunoassay techniques: (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies), with proficiency • Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays • Maintenance of instruments, and address technical and instrumental issues • Assist the Principal Investigator with study conduct • Maintain study documentation • Meet regulatory compliance requirements • Maintain a safe work environment Requirements: Bachelor's degree in related scientific discipline or Bachelors degree with relevant experience • At least 2 years working in a laboratory preferred Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Clinical Diagnostic Solutions, Inc. (CDS) is a company that provides total hematology solutions for the physician office laboratory, clinic, small hospital, and veterinary office markets. At CDS, our mission is to provide the highest quality experience to our valued customers. Our employees achieve this through our cultural goals of working together through Teamwork, high Quality in the work we do, being Innovative and Courageous, always Results Oriented, and most importantly - being Customer Oriented. Under supervision, uses fundamental concepts, practices, and procedures of particular field of specialization to perform scientific, R&D tasks of some complexity requiring application and adaptation of established techniques, procedures, and criteria. Participates in new product development, optimization, validation, and transfer into production. Prioritizes work schedules to support team objectives. Job Responsibilities: Participates in method development and technical innovation within the research team and supports project timelines Performs method optimizations, validations and participates in technology transfer to production Performs routine operation, maintenance, calibration and troubleshooting of laboratory instruments such as pH, conductivity meters, osmometers, spectrnphotometers, hematology analyzers and nucroscopes Evaluates and selects methods, applies protocols and scientific techniques to accomplish study objectives Drafts and updates protocols, test methods and standard operating procedures as applicable Proactively collaborates and supports the team, communicates problems as they arise Provides solution/s to problem/ s of limited complexity, exercises judgment within defined policies to determine appropriate action Collects, analyzes and compiles data. Summarizes for interpretation and discussion Drafts statistical and narrative reports as applicable Recognizes and reports experimental variances Is able to coordinate a small project or a small component of a larger project according to set deliverables Maintains good laboratory records and documentation for experimental work and results Maintains workplace safety and environmental practices Maintains clean workplace including laboratory bench and glassware Supports the department with QC technical investigation activities as needed Works in the spirit of continuous improvement Engages in inter and intra-departmental activities/studies Performs other related duties as required or as directed. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position. Qualifications: Knowledge of scientific approach and methodologies. Ability to design small studies, gather, organize and analyze statistical data and generate reports Excellent oral and written communication skills Ability to investigate and analyze information and to draw conclusions Skill in the use of personal computers and related software applications such as Word/Excel/Powerpoint/Teams Knowledge of current technological developments/trends in area of expertise is desirable but not required Capable of adjusting to dynamic work environment and changing priorities Willing to take on new challenges and implement new ideas Must be Comfortable handling blood products Willing to embrace a learning environment, is open to suggestions, new ideas and innovation Ability to grasp methods fast and willingness to change course as applicable Familiar with GLP, GMP practices and capable of working in a regulated medical device company (ISO and FDA) Must have strong analytical skills Must be a team player and driven individual Must value innovation, accuracy and accountability Minimum Requirements: Bachelor's degree with 2-5 years or Associates degree with 5-8 years' experience that is directly related to the duties and responsibilities specified. EOE

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Job Description: The purpose of Associate Manager/Manager/Senior Manager - Regulatory, is to work cross functionally with Elanco R&D groups, Manufacturing and Quality to develop the global regulatory strategy, oversee submission preparation and meet the reporting requirements for the Authorization and Maintenance of registrations of new animal drugs with global regulatory agencies. Demonstrated knowledge of the drug development process and regulatory submissions with expertise in end-to-end life cycle management (LCM) of a multitude of complex pharmaceutical dosage forms. Design/develop regulatory strategy for geo-expansion of marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. Maintain a positive collaboration and partnership with internal groups in R&D, Quality, Manufacturing and with global regulatory business partners of Elanco. Contribute to pre-submission preparation and proactively communicate regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams, while applying the global strategy into submissions. Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked according to the functional procedures Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends. Minimum Qualification (education, experience and/or training, required certifications): Degree in Science (BSc; MSc, B.Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,) Minimum Experience: 5+ years in Global Regulatory Affairs Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Position is directed toward optimization of existing chemical routes and development of alternate chemistry toward key synthetic intermediates and APIs. Carries out multistep chemical synthesis and product isolation/purification operations in the laboratory, independently or as part of an integrated team. Chemist utilizes modern analytical tools to determine identity and purity of products made during projects. Communication with clients in regular team meetings; prepares R&D reports at the conclusion of projects. Responsibilities Carry out multistep organic syntheses, isolation, and purification of targeted products under supervision or direction of a senior member of the team. Must possess a basic understanding of modern organic synthesis methodologies. The chemist must have a fundamental understanding of modern analytical and spectroscopic techniques and may possess the ability to interpret the corresponding data and spectra. Must demonstrate a proficiency to carry out laboratory syntheses and purification techniques on scales ranging from milligrams to several kilograms. Require minimal supervision and be able to coordinate project activities and resource usage. Demonstrate ability to write comprehensive reports at the conclusion of projects for internal and customer use. With manager input, assist in advising clients on key regulatory guidance. Work to ensure that a spirit of teamwork and cooperation always exists within the group. Conduct laboratory operations in a safe manner. Maintain familiarity with the company's chemical hygiene plan. Exhibit safety awareness and safe work practices. Work closely with manufacturing and GMP operations to coordinate project related equipment and activities. Maintain a clean, safe laboratory work area. This position works with and handles hazardous materials and wastes. Must have the appropriate qualifications to read, understand, apply, and communicate written and verbal information regarding handling and managing hazardous wastes. Training is required within 6 months of assuming duty and once a year thereafter. Responsible for recognizing emergency situation concerning hazardous materials and wastes. Qualifications/Skills Organic Chemistry Knowledge: Strong understanding of the Principles of Organic Chemistry, some process development experience. Cross Discipline Knowledge: Improved understanding of the principles of cross-functional departments, including analytical chemistry and engineering. GMP/Regulatory Knowledge: Demonstrated understanding of GMP as it relates to current work. With less manager input, can help to advise clients on key regulatory strategies. Instrumentation: Demonstrated ability to use, train, investigate root cause issues with HPLC, GC, good understanding of MS, uses automated reactors, may have some experience with In-situ reaction monitoring. Communication: Good written and oral communication skills, ability to handle client requests with manager review. Problem Solving: Able to solve problems in the workplace and helps to lead investigations with manager support. Time Management: Good understanding of time management and can self-organize with or without supervision. Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up. Technical Documentation and Review: Ability to write and review reports and technical documents with minimal RFT errors, keep current lab notebook while practicing GDP. External Influence: Actively participates in regular internal project team meetings, including submission of key technical reports; organizes group level initiatives within the larger scientific team. Industry Credibility and Rapport: Known as a solid scientific contributor within the department/group Operational Excellence: Able to support key OE initiatives. Change Orientation: Locally supports changes associated with larger Cambrex initiatives. Education, Experience & Licensing Requirements Ph. D. in Chemistry or related field with minimum 2 years' experience or M. S. in Chemistry or related field with minimum 6 years' experience or B. S. degree in Chemistry or related field with 10 years of experience in lab environment, pharmaceutical experience preferred. Hands on experience in pharmaceutical/chemical process development. Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (SharePoint, Word / EXCEL / PowerPoint), and Chemdraw is expected. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-SK1Ph. D. in Chemistry or related field with minimum 2 years' experience or M. S. in Chemistry or related field with minimum 6 years' experience or B. S. degree in Chemistry or related field with 10 years of experience in lab environment, pharmaceutical experience preferred. Hands on experience in pharmaceutical/chemical process development. Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (SharePoint, Word / EXCEL / PowerPoint), and Chemdraw is expected. Carry out multistep organic syntheses, isolation, and purification of targeted products under supervision or direction of a senior member of the team. Must possess a basic understanding of modern organic synthesis methodologies. The chemist must have a fundamental understanding of modern analytical and spectroscopic techniques and may possess the ability to interpret the corresponding data and spectra. Must demonstrate a proficiency to carry out laboratory syntheses and purification techniques on scales ranging from milligrams to several kilograms. Require minimal supervision and be able to coordinate project activities and resource usage. Demonstrate ability to write comprehensive reports at the conclusion of projects for internal and customer use. With manager input, assist in advising clients on key regulatory guidance. Work to ensure that a spirit of teamwork and cooperation always exists within the group. Conduct laboratory operations in a safe manner. Maintain familiarity with the company's chemical hygiene plan. Exhibit safety awareness and safe work practices. Work closely with manufacturing and GMP operations to coordinate project related equipment and activities. Maintain a clean, safe laboratory work area. This position works with and handles hazardous materials and wastes. Must have the appropriate qualifications to read, understand, apply, and communicate written and verbal information regarding handling and managing hazardous wastes. Training is required within 6 months of assuming duty and once a year thereafter. Responsible for recognizing emergency situation concerning hazardous materials and wastes.