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Senior Associate Scientist jobs at Johnson & Johnson

- 1056 jobs
  • Senior Scientist, Process Validation

    Johnson & Johnson 4.7company rating

    Senior associate scientist job at Johnson & Johnson

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Manufacturing Job Sub Function: Manufacturing Deployment Job Category: Professional All Job Posting Locations: New Brunswick, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for a Senior Scientist, Process Validation to be based New Brunswick, New Jersey. Alternative locations include Raritan, New Jersey. Our Global Focus in Advanced Therapies Advanced therapy medicinal products (ATMPs), including CAR-T and viral vector-based treatments, represent a transformative approach to patient care. As a global organization, we strive to harmonize validation strategies, ensuring consistency, compliance, and innovation throughout our manufacturing network. The Process Validation Center of Excellence The CoE provides strategic leadership for validation activities and governance standards to drive accountability across partners. We define standard processes, drive harmonization, and enable technology adoption to ensure robust, validated processes that meet regulatory expectations and deliver life-changing therapies to patients worldwide. Role Summary The Senior Scientist serves as a key member of the global Life Cycle Management team, responsible for developing, implementing, and governing validation strategies across the Advanced Therapies network. This role focuses on global alignment, standardization of validation approaches, and strategic oversight of Tech Transfer, PPQ campaigns, CPV programs, and digital readiness. This role partners closely with regional MSAT, R&D, Quality, Regulatory, and Engineering teams to ensure consistent, compliant, and innovative validation practices globally. Operational Excellence & Governance Define and maintain global Validation Master Plans and governance frameworks for ATMP processes. Drive global implementation of risk-based validation approaches aligned with ICH Q8/Q9/Q10, Annex 15, and FDA/EMA guidance. Author harmonized validation standards and templates across the global network. Provide strategic oversight for PPQ campaigns implemented at multiple sites, ensuring consistency and compliance. Support global CPV strategy, apply data analytics, statistical tools, and risk management principles to evaluate process capability and drive data-informed decisions. Support lifecycle improvement initiatives and evaluate digital tools for process monitoring. Partner with regional and site teams to assess validation readiness for new technologies and platforms. Support and author regulatory submissions with globally aligned validation documentation and strategies. Cross-Functional Leadership & Communication Act as an inspiring leader, mentoring teams and influencing global validation policy and innovation. Facilitate collaboration and communicate program goals, progress, risks, and results to senior leadership and technical teams with clarity and influence. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s) United States - Requisition Number: R-048421 Belgium - Requisition Number: R-049802 Ireland - Requisitions Number: R-049778 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Required Qualifications: Education: Bachelor's degree in biology, biotechnology, or related scientific field is required; advanced degree or equivalent experience preferred. Skills & Experience: 7+ years proven experience within a regulated biologics or pharma industry Experience in global process validation strategy, governance, and regulatory compliance for ATMPs. Strong understanding of risk-based validation principles and Health Authority expectations. Demonstrate the ability to work effectively in cross-functional environment and influence global teams Preferred Qualifications: Prior experience in cell culture or viral vector commercial manufacturing is highly desired. Knowledge in statical process control and analytical data modeling. Experience in digital solution implementation and deployment. Knowledge in data management platforms and data governance Other Requirements: International travel to partner sites and global meetings, up to 20% of the time. Flexibility to work remotely when not travelling. Language requirements - fluency in English required; additional languages preferred. The anticipated compensation rage for this position is 94,000-144,500 Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************** Required Skills: Preferred Skills: Agile Manufacturing, Business Process Design, Coaching, Communication, Critical Thinking, Good Manufacturing Practices (GMP), Innovation, Manufacturing Engineering, Manufacturing Flow Management, Manufacturing Processes, Plant Operations, Proactive Behavior, Problem Solving, Product Development Lifecycle, Production Operations, Profit and Loss Responsibility, Robotic Automation, Structural Fabrication, Sustainability The anticipated base pay range for this position is : 94,000-144,500 Additional Description for Pay Transparency: Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $72k-99k yearly est. Auto-Apply 5d ago
  • R&D Scientist

    EPM Scientific 3.9company rating

    Chicago, IL jobs

    Are you passionate about science and organization? We're looking for a hands-on scientist who can also drive project coordination across R&D and analytical initiatives. This role blends technical expertise with leadership in planning and communication. What You'll Do Track and manage R&D and analytical projects, ensuring timelines and priorities are met. Maintain project dashboards and prepare concise progress updates for leadership. Support formulation experiments, sample prep, and analytical testing (HPLC, dissolution, stability). Collaborate with QA, Regulatory, and Operations to align deliverables. Recommend process improvements and help implement standardized tools. What We're Looking For Education: Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Experience: 3-6 years in pharmaceutical R&D, analytical chemistry, or formulation science. Familiarity with HPLC and method development. Strong organizational and communication skills. Comfortable balancing lab work with coordination responsibilities. Why Join Us Competitive salary + comprehensive benefits. Health, dental, vision coverage. Retirement plan with company match. Paid time off and holidays. Collaborative, science-driven environment.
    $70k-96k yearly est. 3d ago
  • Senior Scientific Associate - Market Access Marketing

    Precision Medicine Group 4.1company rating

    Remote

    PRECISION AQ, the top payer marketing agency, supports global pharmaceutical and life sciences clients in the achievement of commercial excellence. We excel at demonstrating the economic, clinical, and societal value of creative medical treatments to payers, providers, patients, and policymakers. As leaders in the generation, analysis, and communication of that evidence, we are improving market access and supporting our clients in their mission of improving care for patients around the world. As a Senior Scientific Associate, you will write medical content for our clients working with internal teams to ensure that the client vision is achieved impacting our clients who are developing groundbreaking medicines/treatments who are working to make medicines accessible and affordable. We provide external training, mentorship, and operate in a cross-functional project team environment. About You: You have a strong interest in managed markets and consider yourself a life-long learner You enjoy writing and researching You stay on top of trends in the medical/scientific community You love rolling up your sleeves and taking projects from start to finish You have an eye for detail and can accurately convey complex information in a simple way You are passionate about providing medical insights, supplying creative ideas, and developing high quality content that allows you to use scientific/medical knowledge and demonstrate your writing skills What you can expect day-to-day: Serving as medical point person on assigned accounts Developing, writing and translating complex scientific data to a broad audience across multiple and wide-ranging therapeutic areas Ensuring project quality and outcomes by demonstrating in depth technical expertise of assigned therapeutic category and/or managed care areas Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.) Working closely with account teams to refine content in keeping with strategic imperatives Communicating medical content with internal team and pharmaceutical clients, as necessary Attending medical, legal, regulatory review meetings Participating in internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings Chipping in ideas for new business proposals and tactical planning within assigned accounts Mentoring junior level writers Qualifications: Doctorate level degree such as PharmDs or PhDs 2-4 years in medical communications, healthcare agency, medical education, or similar field Ability to translate complex scientific concepts for a variety of managed care audiences Ability to prioritize projects, juggle competing client priorities & meet deadlines without sacrificing quality Flexibility to meet the demands of a dynamic environment Strong written and verbal social skills Ability to travel for occasion Other Candidates with a BA/BS plus a minimum of 3 years of experience in the medical communication, pharmaceutical and/or healthcare industry can be considered for Senior Medical Writer level #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$75,000-$122,500 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $75k-122.5k yearly Auto-Apply 11d ago
  • Scientific Associate

    Precision Medicine Group 4.1company rating

    Remote

    The Scientific Associate (SA) is responsible for developing and writing medical content for their assigned account(s) and works in conjunction with all internal teams to ensure that the client vision is achieved and content is medically accurate. The SA is responsible for development of a variety of resources, including, but not limited to, clinical monographs, value proposition slide decks, advisory board materials, and internal training resources. Essential functions of the job include but are not limited to: (This is NOT meant to be an exhaustive task list) • Under direct supervision, develop high quality, medically accurate content in print or digital format for a wide range of medical communication resources • Deliver requested projects per established timelines • Conduct literature reviews and develop annotations to support promotional claims in a variety of promotional medical education and marketing resources • Ensure professional, proactive, and collaborative communication with internal and external stakeholders • Ensure a constant high quality of work in line with science, good publication practice, and company rules and policies • Work closely with account teams to refine content in keeping with strategic imperatives • Communicate medical content with internal team and pharmaceutical clients, as necessary • Attend medical, legal, regulatory review meetings and participate, as necessary • Participate in all internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings • Contribute ideas for tactical planning within assigned accounts • Travel for occasional client meetings • Promote and adhere to Precision Value and Health's workplace values known as PRECISION Principles (Client Service, Purpose, Accountability, Mutual Respect and Collaboration) Required Education: • Advanced degree in life sciences, preferably PharmD or PhD Required Experience: • 1 - 2 years of experience in the medical communication, pharmaceutical and/or healthcare industry. Required Skills: • Knowledge of American Medical Association (AMA) style • Proficiency in Microsoft Word, Microsoft PowerPoint, and Adobe Acrobat • Familiarity with scientific search engines including PubMed and Google Scholar Required Competencies: • Strong written and verbal communication • High analytical ability • Ability to prioritize deadline-sensitive projects and juggle competing client priorities • Team- and detail-oriented Preferred Qualifications: • Expertise in gathering, evaluating, and summarizing healthcare business and scientific literature and insights data for a variety of managed care audiences • Working knowledge of managed markets, healthcare, and the healthcare delivery system; health reform legislation; and/or managed care experience (HMO, MCO, PBM, etc.) • Managed care experience #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$83,000-$117,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $83k-117k yearly Auto-Apply 2d ago
  • Associate Principal Scientist, Downstream Vaccines and Advanced Biotechnologies Process R&D

    MSD 4.6company rating

    Point, PA jobs

    Associate Principal Scientist - Downstream Vaccines and Advanced Biotechnologies Process R&D Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for all of our company's pipeline. Our Discovery Interface team works closely with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology, and seeks to embed developability/manufacturability considerations into early research discussions in order to enable more seamless and rapid progression of candidates from Discovery into Process Development and Clinical Supply Manufacturing. We are seeking an innovative, highly motivated, and experienced Associate Principal Scientist to join us at our research and development site in West Point, PA (outside Philadelphia). The candidate will be responsible for scientific/technical leadership of a downstream/bio-purification process development team, and will also be a critical member of cross-functional program/project teams. This will require frequent collaboration with cross-functional teams including colleagues in Discovery, Analytical, Formulation, and Enabling Technologies. The candidate should have a strong background in recombinant protein therapeutic/vaccine process design and understanding of various purification modalities, including but not limited to column chromatography (SEC, IEX, Affinity, MMC, HIC, etc.) and filtration unit operations (depth filtration, sterile filtration, viral filtration, TFF), as well as advanced knowledge in peptide/protein handling and purification techniques. Alternatively, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Preferably, the candidate will have experience with both recombinant protein purification and conjugation process development. Primary responsibilities include, but are not limited to: Lead early downstream process design and development for recombinant subunit and/or conjugate vaccine products. Contribute to the development of new principles, concepts, methods, and workflows to enable rapid early process development for new molecules emerging from Discovery. Design, execute, and analyze process development experiments to maximize understanding of recombinant subunit and/or conjugate vaccine production processes, thereby de-risking later stage process/product development. Represent functional area in cross-functional and strategic teams engaged in novel vaccine development. Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of downstream/bio-purification process development for vaccines and advanced biotechnologies. Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development. Analysis of downstream/bio-purification experiments through basic analytical techniques including SDS-PAGE, UV-Vis, HPLC, Light Scattering Data interpretation and presentation, manuscript/patent preparation Education Minimum Requirement: Must have a BS or MS or PhD in engineering or biological sciences Engineering: Chemical Engineering, Bioengineering, Biomedical Engineering Science and Technology: Cell Biology, Biological Sciences, Biotechnology For BS candidates, at least seven (7) years of experience in a pharmaceutical or biotechnology-related position. For MS candidates, at least five (5) years of experience in a pharmaceutical or biotechnology-related position. For PhD candidates, at least three (3) years of experience in a pharmaceutical or biotechnology-related position. Required Experience and Skills: Must have strong scientific and hands-on understanding of a wide variety of common downstream unit operations for large molecule purification (e.g., depth filtration, chromatography, tangential flow filtration), biotherapeutic and/or vaccine production, and purification process development and sound understanding of scale-up principles. At least 5 years of hands-on experience in the optimization of downstream processes Some prior experience with statistical design of experiments (DOE) and/or algorithmic process optimization. Strong understanding of, or hands-on experience in, cGMP manufacturing. Ability to work effectively both independently and in a team-focused environment. Well-developed organizational, record-keeping, and timeline/resource-mapping skills. Preferred Experience and Skills: Experience in purification unit operations using AKTA platform (or similar FPLC system) Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates) Demonstrated knowledge of peptide and protein biochemistry (e.g., structure, function, immunology), and cutting-edge methodologies related to protein isolation/purification Experience in mentoring others and leading small technical development teams Experience in authoring and reviewing CMC regulatory documentation Experience with process and technology transfer The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for him/herself and his/her team. Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Some travel may be required. This position may require occasional off-hour and weekend work. PRD Required Skills: Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Biomedical Engineering, Biomedical Sciences, Biomedical Technologies, Cell Line Development, Column Chromatography, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunoassays, Innovation, Interpersonal Relationships, Laboratory Safety, Leading Project Teams, Machine Learning (ML), Mechatronics, Molecular Biology, Neurotrophins, Pharmaceutical Formulations, Pharmaceutical Process Development {+ 3 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 12/26/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
    $62k-87k yearly est. Auto-Apply 24d ago
  • Technical Services Manufacturing Scientist - Downstream

    Elanco 4.9company rating

    Elwood, KS jobs

    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! Your Role: Technical Services Manufacturing Scientist - Downstream The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial downstream operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects. Your Responsibilities: Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation. Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements. Develop / execute projects to address process performance issues and deliver improvement opportunities. Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports. What You Need to Succeed (minimum qualifications): Education: Bachelor's degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: Experience in the Biotech / Pharmaceutical industry. Detailed understanding of biopharmaceutical production processes and technologies. Working knowledge of cGMP standards and experience working in a regulated environment. Proven analytical thinking and problem-solving skills. What will give you a competitive edge (preferred qualifications): MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline. Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes. Experience in tech transfer, scale up, and validation of biopharmaceutical processes. Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools. Working knowledge of USDA and/or EU GMP regulations for veterinary biologics. Additional Information: Location: Elwood, Kansas. Day shift position. Weekend work on a rotation to provide process support to ongoing operations. Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: Multiple relocation packages for eligible roles Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave 9 Employee Resource Groups Annual bonus offering Up to 6% 401K matching #LI_MNLC 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
    $59k-78k yearly est. Auto-Apply 40d ago
  • Scientific Report Associate - Lincoln, Nebraska

    Celerion 4.2company rating

    Lincoln, NE jobs

    Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is searching for a full-time Scientific Report Associate for our Lincoln, NE location. This position will generate, template, and format preliminary and final Clinical Study Reports. This position will build appendices, import information from various sources and format the report per client specifications related to margins, fonts, table formats, hyperlinks, bookmarks and styles. Requirements: A Bachelor's degree or at least 1 year relevant experience in a related field preferred. Proficiency with MS Word, and Business English are essential. The ability to manage multiple priorities and high attention to detail is required. Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $53k-78k yearly est. Auto-Apply 60d+ ago
  • Associate R&D Process Scientist

    Perrigo Company Corporate 4.9company rating

    Eau Claire, WI jobs

    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
    $62k-84k yearly est. 30d ago
  • Associate I, Scientific Report Writing

    Qps Holdings, LLC 4.5company rating

    Newark, DE jobs

    Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! As a junior member of our Scientific Report Writing team, you will play an integral part in the generation of clear and concise documents that summarize the scientific data that is used by the pharmaceutical industry to advance drug development. Assignments will include minimally complex reports, where your intellectual abilities are required to identify problems and make recommendations. Please note that this position is fully onsite. No visa sponsorship (e.g. H‑1B, L‑1, E) will be provided for this active position, now or in the future. Applicants must currently be authorized to work in the U.S. on a permanent or unrestricted basis. QPS' Story: Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II - IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life. Team members enjoy challenging and rewarding work, and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals. If this sounds like your ideal work environment, then we would love to speak with you, so apply today! Please visit our website (************ for more information and to see all current openings. The Job Write clear and concise documents which summarize scientific data, utilizing QPS or Client templates to generate all final written GLP and Non-GLP reports for clients, including method validation reports, sample analysis reports, and amendments. Drive the document preparation process, receive and review study notebooks from scientists, draft and distribute document for review, and compile comments and edits as necessary. Interpret and evaluate data to identify potential errors, using academic knowledge, logic, and mathematical equations. Ensure reports are accurate and complete, and adhere to standards for quality, format, style, and accuracy. Generate data tables using Watson LIMS. Work Location This job will be 100% QPS-office/facility based Requirements Bachelor's level degree in Biology, Chemistry, or related scientific discipline Some prior scientific report writing experience preferred Basic understanding of the theoretical basis of methods and experiments Must have the ability to interpret scientific data study notebooks Excellent grammar and writing skills utilizing MS Office (Word, Excel) and Adobe Why You Should Apply Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals. Structured Career Ladders that provide excellent growth based on your personal aspirations. Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance. Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance Internal committees designed with the needs and enjoyment of QPS employees in mind. QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.
    $92k-140k yearly est. Auto-Apply 17d ago
  • Senior Scientist - Formulation Development

    Nivagen Pharmaceuticals 3.7company rating

    Sacramento, CA jobs

    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.
    $70k-90k yearly Auto-Apply 58d ago
  • Toxicologist

    Zoetis 4.9company rating

    Remote

    Zoetis Veterinary Medicine Research and Development (VMRD) seeks a skilled Toxicologist to join the Toxicology Group within Clinical Pharmacology and Safety Sciences based in Kalamazoo, MI. This challenging and dynamic role provides global toxicology and safety assessment support. The successful candidate will collaborate across VMRD and Global Manufacturing and Supply (GMS) to develop scientifically rigorous safety assessments supporting product safety across therapeutic areas, veterinary species, human health, and manufacturing processes. Responsibilities: Toxicological Assessment for Drug Products: Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products Toxicological Assessment for Manufacturing: Qualify impurities in the manufacturing process of APIs and drug products; conduct safety assessments for extractables and leachables, cross-contamination of products in shared facilities, and establish cleaning limits. Occupational Safety: Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures. User and Worker Safety: Provide product user and worker safety support for project teams, including risk assessments, exposure scenario calculations, risk mitigation proposals, packaging recommendations and label language development. Safe Exposure Level Development: Establish Threshold of Toxicological Concern (TTC) and health-based exposure limits, including Permitted Daily Exposure (PDE), Acceptable Daily Intake (ADI), and Margin of Exposure (MoE). Health Hazard/ Medical Assessments: Support pharmacovigilance, product quality, and qualification of out-of-specification batches. Regulatory Support: Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products. Toxicology Data Analysis & Literature Review: Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration. Hazard Communication and Chemical Regulatory Compliance (Preferred): Experience in preparing Safety Data Sheets (SDS), classifying drug substances and process intermediates according to the Globally Harmonized System (GHS) and national requirements, and horizon scanning and monitoring of chemical regulations. Cross-Collaboration and Technical Leadership: Engage in multidisciplinary collaboration within R&D, and with Manufacturing, Product Quality, and Sustainability, to develop and integrate key knowledge areas and expertise into actionable business insights. Regulatory & Scientific Engagement: Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology. Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed. Minimum Qualifications Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline is critical. Master's degree in toxicology or closely related discipline with 8 years of relevant experience shall be considered. Demonstrated experience in preparing regulatory-quality technical documents or toxicology dossiers, with strong technical writing skills (e.g., protocols, reports, journal articles) Experience in study design, implementation, and interpretation of studies evaluating in vivo and in vitro toxicity or similar experience. Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments. Ability to prioritize tasks, make informed decisions, and collaborate effectively in a global matrix environment. Excellent verbal and written communication skills in English. Proficiency in MS Office, and toxicology databases for literature research and data analysis Desirable Skills, Experience, and Attributes: Board certification in toxicology (e.g., DABT, ERT) and/or DVM. Knowledge of global regulatory requirements for toxicology risk assessment and documentation to support product safety and chemical registrations. Experience in preparing safety data sheets. The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors. Base Pay Range: $91,000 - $131,000 The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors. Base Pay Range: $103,000 - $148,000 [This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.] We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $103k-148k yearly Auto-Apply 60d+ ago
  • Scientist- Biologics

    Frontage Lab 3.9company rating

    Exton, PA jobs

    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. *
    $52k-78k yearly est. 60d+ ago
  • Scientist- Biologics

    Frontage Laboratories 3.9company rating

    Exton, PA jobs

    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.
    $52k-78k yearly est. 14d ago
  • Scientist- Biologics

    Frontage Laboratories 3.9company rating

    Exton, PA jobs

    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.
    $52k-78k yearly est. Auto-Apply 60d+ ago
  • Senior Scientific Associate - Market Access Marketing

    Precision Medicine Group 4.1company rating

    New York jobs

    PRECISION AQ, the top payer marketing agency, supports global pharmaceutical and life sciences clients in the achievement of commercial excellence. We excel at demonstrating the economic, clinical, and societal value of creative medical treatments to payers, providers, patients, and policymakers. As leaders in the generation, analysis, and communication of that evidence, we are improving market access and supporting our clients in their mission of improving care for patients around the world. As a Senior Scientific Associate, you will write medical content for our clients working with internal teams to ensure that the client vision is achieved impacting our clients who are developing groundbreaking medicines/treatments who are working to make medicines accessible and affordable. We provide external training, mentorship, and operate in a cross-functional project team environment. About You: You have a strong interest in managed markets and consider yourself a life-long learner You enjoy writing and researching You stay on top of trends in the medical/scientific community You love rolling up your sleeves and taking projects from start to finish You have an eye for detail and can accurately convey complex information in a simple way You are passionate about providing medical insights, supplying creative ideas, and developing high quality content that allows you to use scientific/medical knowledge and demonstrate your writing skills What you can expect day-to-day: Serving as medical point person on assigned accounts Developing, writing and translating complex scientific data to a broad audience across multiple and wide-ranging therapeutic areas Ensuring project quality and outcomes by demonstrating in depth technical expertise of assigned therapeutic category and/or managed care areas Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.) Working closely with account teams to refine content in keeping with strategic imperatives Communicating medical content with internal team and pharmaceutical clients, as necessary Attending medical, legal, regulatory review meetings Participating in internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings Chipping in ideas for new business proposals and tactical planning within assigned accounts Mentoring junior level writers Qualifications: Doctorate level degree such as PharmDs or PhDs 2-4 years in medical communications, healthcare agency, medical education, or similar field Ability to translate complex scientific concepts for a variety of managed care audiences Ability to prioritize projects, juggle competing client priorities & meet deadlines without sacrificing quality Flexibility to meet the demands of a dynamic environment Strong written and verbal social skills Ability to travel for occasion #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $87,500 - $122,500 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
    $87.5k-122.5k yearly Auto-Apply 60d+ ago
  • Formulation Development Senior Scientist

    Aerogen 4.4company rating

    Foster City, CA jobs

    Pharma Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system. We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year. Join us as we embark on this breakthrough and become inspired to deliver. What is the role? The person in this role is responsible for establishing and maintaining a state-of-the-art formulation development laboratory, working in close collaboration with the analytical development laboratory manager, to support our efforts in developing commercially viable lipid-peptide and lipid-protein multi laminar vesicle formulations (MLVs). This role is crucial for advancing our CMC program for the Gates project, as well as establishing formulation capabilities and in-house expertise in our expanding portfolio, ensuring products meets rigourous quality and regulatory standards. The person will be both hands on in the lab with deep technical knowledge, as well as mentor and manage direct reports, and will collaborate effectively with our external GMP testing and manufacturing partners. What are the key responsibilities? Lab design, establishment and operations: Establish state-of-the-art process development laboratory that develops lipid-peptide and lipid-proteins MLV formulations. Ensure efficient and safe lab operations. Mentorship and managing direct reports: Hire and mentor staff and manage direct reports. Formulation development: Provide guidance and hands on support for the design and optimization of lipid-peptide and lipid-protein MLV formulations. CDMO/CMO Collaboration: Ensure effective communications and coordination with our GMP partners to meet project timelines and quality expectations. Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to regulatory requirements. Cross-Functional Collaboration: Work closely with R&D, Regulatory, Quality Assurance, and Manufacturing teams to integrate formulation science efforts within overall project goals. Troubleshooting & Problem Solving: Address and resolve complex process issues during development and manufacturing. Continuous Improvement: Stay updated on advancements in process engineering equipment, techniques and industry trends. What Education and Experience are required? A Ph.D. in Chemistry, Engineering, Biochemistry or related field. 3-10 years of process development experience. Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus. Experience in technical writing is required. Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus. Knowledge and experience in drug-device development, inhalation drug delivery is a plus. Excellent written and oral communication skills. What key skills will make you great at the role? Technical expertise: Proficiency in formulation design and equipment required for lipid-peptide / lipid-protein formulations. Experience with drug-device combination products is a plus. Deep understanding of laboratory procedures, equipment, software, and data analysis. Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance. Leadership, management and communication skills: Motivate, inspire, and lead technical staff. Clearly and effectively communicate with team members, other departments, and upper management. Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab's objectives. Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment. Compliance and safety: Ensure a safe and complaint work environment. Training, procedures, quality: Schedule training for staff to ensure they are up-to-date on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements. Why Aerogen Pharma? As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.
    $127k-179k yearly est. 4d ago
  • Senior Scientist, Formulation Development

    Fenwal 4.3company rating

    Melrose Park, IL jobs

    Job SummaryThe Senior Scientist is responsible for conducting development studies with increasing complexity in nature and solving problems to ensure a stable product can be manufactured in the production facility. requires working onsite at our Innovation and Development Center in Melrose Park, IL. • This position is not eligible for sponsorship either now or in the future. • Salary Range: $85,000-100,000 • Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary. • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities Accepts responsibility for all stages of product development including on-site monitoring of stability lot manufacturing. Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development. Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems. Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements. Scales up the manufacturing process and transfers the technology accurately to the production plant. Sets product specifications based on stability results and according to FDA and ICH guidelines. Writes Chemistry, Manufacturing and Control (CMC) section for Regulatory submission. Responsible for product and process improvement as well as for ideas for new products, line-extent, product stability improvement and novel drug delivery systems. Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule. Job Requirements: Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5+ years of related experience; or a Master's Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 3 years of related experience; or a PhD in Pharmaceutical Sciences, Chemistry, Biological Sciences, Chemical/Biomedical Engineering with 0-3 years of related experience is required. Must possess skills of designing and executing experiments using different lab instruments and techniques. Must have knowledge of statistic and analysis/interpretation, and pharmaceutical dosage forms. Experience in developing novel drug delivery systems is a plus. Must be willing to perform drug product development for potent compounds, cytotoxic substances and/or controlled substances while following and observing all safety procedures in place, which include the use of engineering controls, administrative controls, Standard Operating Procedures (SOPs), training, and Personal Protective Equipment (PPE). Must be willing to travel domestically and internationally to production plant to support batch manufacturing, etc. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
    $85k-100k yearly Auto-Apply 52d ago
  • Scientist I, Production

    Cole-Parmer Instrument Company 4.2company rating

    North Charleston, SC jobs

    Job Title: Scientist, Production Reports To: Manager, Operations Work Type: Onsite FLSA Status: Non-exempt Individuals serving in this position will be working in manufacturing, product development, and Quality testing at the Diagnostics business units. Employees will be trained in a variety of lab techniques specific to the department assigned as well as document generation and completion. The incumbent must be a dynamic individual who can multi-task and perform various activities associated with manufacturing operations while adhering to all safety policies and high quality Standard Operating Procedures. This position requires hands on lab work and will report to the Lab or Production Manager. Key Responsibilities: · Execution of quality system procedures · Proper execution of SOPs, safety guidelines, and work instructions for manufacturing procedures assigned by supervisor · Ability to work individually as well as part of a team towards completion of specific projects · Use of manufacturing related equipment as required by work instructions and SOPs · Data analysis · Demonstration of sound problem-solving skills and troubleshooting abilities · Communicate exceptions to established/agreed upon schedules to all affected parties internal and external. · Adherence to quality systems with special regard to FDA, ISO 13485 and GMP / OSHA compliance · QC testing of components and finished products including organization of inventory, weighing actual hands-on inventory and updating systems. · Inventory management of materials and supplies · Focus on continual process improvement · Cleaning and maintenance of equipment · Guided experimental design and product testing assigned by supervisor · Preparation of reagents, media, and buffers · Performs other duties as assigned Department Specific Potential Duties: Chemistry · Assist and manufacture inorganic or organic products using knowledge of chemistry principles. · Experience with general chemistry glassware, lab supplies and concentrated acid handling · Experience with hot block digestion, auto pipettes, and sample preparation preferred. · Basic mathematics and familiarity with general chemistry calculations Experience: · 4-year B.S. degree required in biology, microbiology, chemistry, or other life sciences program · Relevant experience in laboratory skills/cGMP preferred. Including but not limited to pipetting, preparing reagents, centrifugation, recording observations, etc. Qualifications: · Ability to analyze and interpret data and results · Proficiency in Microsoft Office · Strong analytical, problem solving, process improvement skills · Attention to detail · Ability to multitask and adapt to changing priorities · Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints · Excellent communication skills, both written and verbal, to communicate to all levels of the organization clearly and concisely · Strong work ethic and an ability to excel within a rapidly changing and growing organization · Willingness to cross train and support other teams as needed for our medium sized business. Physical Requirements/Working Conditions: · Potential Hazards: solvents, acids, bases, infectious organisms, carcinogens, combustibles, fast paced environment, repetitive motion, · Recommended PPE: Closed toe shoes, lab coats, gloves, safety goggles, Tyvek suits in level three biohazard laboratories Compensation & Benefits: Salary Range: $20/hr-$36/hr, depending on location, experience, and qualifications. Benefits coverage begins day 1, including the following: Medical, Dental, Vision Insurance Disability Insurance Life Insurance 401(k) company match Paid Time Off (15 days annually) Paid Holiday time (10 company-designated days) Tuition Assistance Additional benefits available with company package This position has not been approved for Relocation Assistance. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
    $20 hourly Auto-Apply 60d+ ago
  • Toxicologist

    Zoetis 4.9company rating

    Kalamazoo, MI jobs

    Zoetis Veterinary Medicine Research and Development (VMRD) seeks a skilled Toxicologist to join the Toxicology Group within Clinical Pharmacology and Safety Sciences based in Kalamazoo, MI. This challenging and dynamic role provides global toxicology and safety assessment support. The successful candidate will collaborate across VMRD and Global Manufacturing and Supply (GMS) to develop scientifically rigorous safety assessments supporting product safety across therapeutic areas, veterinary species, human health, and manufacturing processes. Responsibilities: Toxicological Assessment for Drug Products: Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products Toxicological Assessment for Manufacturing: Qualify impurities in the manufacturing process of APIs and drug products; conduct safety assessments for extractables and leachables, cross-contamination of products in shared facilities, and establish cleaning limits. Occupational Safety: Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures. User and Worker Safety: Provide product user and worker safety support for project teams, including risk assessments, exposure scenario calculations, risk mitigation proposals, packaging recommendations and label language development. Safe Exposure Level Development: Establish Threshold of Toxicological Concern (TTC) and health-based exposure limits, including Permitted Daily Exposure (PDE), Acceptable Daily Intake (ADI), and Margin of Exposure (MoE). Health Hazard/ Medical Assessments: Support pharmacovigilance, product quality, and qualification of out-of-specification batches. Regulatory Support: Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products. Toxicology Data Analysis & Literature Review: Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration. Hazard Communication and Chemical Regulatory Compliance (Preferred): Experience in preparing Safety Data Sheets (SDS), classifying drug substances and process intermediates according to the Globally Harmonized System (GHS) and national requirements, and horizon scanning and monitoring of chemical regulations. Cross-Collaboration and Technical Leadership: Engage in multidisciplinary collaboration within R&D, and with Manufacturing, Product Quality, and Sustainability, to develop and integrate key knowledge areas and expertise into actionable business insights. Regulatory & Scientific Engagement: Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology. Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed. Minimum Qualifications Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline is critical. Master's degree in toxicology or closely related discipline with 8 years of relevant experience shall be considered. Demonstrated experience in preparing regulatory-quality technical documents or toxicology dossiers, with strong technical writing skills (e.g., protocols, reports, journal articles) Experience in study design, implementation, and interpretation of studies evaluating in vivo and in vitro toxicity or similar experience. Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments. Ability to prioritize tasks, make informed decisions, and collaborate effectively in a global matrix environment. Excellent verbal and written communication skills in English. Proficiency in MS Office, and toxicology databases for literature research and data analysis Desirable Skills, Experience, and Attributes: Board certification in toxicology (e.g., DABT, ERT) and/or DVM. Knowledge of global regulatory requirements for toxicology risk assessment and documentation to support product safety and chemical registrations. Experience in preparing safety data sheets. The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors. Base Pay Range: $91,000 - $131,000 The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors. Base Pay Range: $103,000 - $148,000 [This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentive.] We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $103k-148k yearly Auto-Apply 60d+ ago
  • Associate Scientist - R&D

    Clinical Diagnostic Solutions 4.8company rating

    Plantation, FL jobs

    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
    $49k-76k yearly est. 60d+ ago

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