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  • 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 21d 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. 27d ago
  • Technical Services Manufacturing Scientist (TSMS) Associate- Pilot Scale

    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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise. 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 Science (TSMS) Associate -Pilot Scale The Technical Services & Manufacturing Science (TSMS) Associate is responsible for providing operational and technical support for commercial and pilot laboratory 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. Your Responsibilities: Support the execution and troubleshooting of upstream and/or downstream manufacturing processes for biologics (e.g., mammalian cell culture, purification). Collaborate with Manufacturing, Development, and Quality teams in the execution of technical / development studies, investigations, validation activities, and technical transfer programs, and collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and likelihood of technical success. Provide on-floor support during manufacturing campaigns, including troubleshooting and deviation investigations. 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. Author and provide critical review of technical documents, including, but not limited to: batch records, SOPs, PFDs, risk assessments, investigations, technical studies, commissioning and qualification protocols, and reports. Assist in implementing changes through the change control system (e.g., BOM updates, process changes). What You Need to Succeed (minimum qualifications): Education: Bachelor's degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: 0 - 2 years' experience in the Biotech / Pharmaceutical industry. Familiarity with tools such as JMP or Excel for data analysis is a plus. Ability to work in a team environment and support manufacturing activities on the production floor, including occasional off-shift or weekend support if required. Detailed understanding of biopharmaceutical production processes and technologies with working knowledge of cGMP standards and experience working in a regulated environment. What will give you a competitive edge (preferred qualifications): MSc in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. 3+ years' experience in the Biotech / Pharmaceutical industry. Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes. Experience in tech transfer, scale-up, and validation of biopharmaceutical processes. Experience in capital project design, development, validation, and execution. Experience with electronic quality systems (e.g., Veeva QMS, TrackWise) and MES platforms. Additional Information: Location: Elwood, Kansas Day shift position. Weekend and evening work is not usual, although it may be required to provide process support to ongoing operations. Minimal travel requirements < 10%. Don't meet every single requirement? Studies have shown underrecognized 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 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 Flexible work arrangements Up to 6% 401K matching 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 60d+ 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 36d ago
  • Scientist II, Discovery, Targeted Therapy

    Astellas Pharma 4.9company rating

    Cambridge, MA jobs

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Purpose and Scope:** The Discovery Targeted Therapy Research team at Astellas is seeking a highly accomplished and visionary scientist to drive innovative research initiatives in oncology drug discovery. This role is ideal for a candidate who has a proven track record of successfully designing, executing, and leading discovery-phase research programs targeting cancer biology. The candidate will be responsible for being a member of a research program team to generate new ideas, develop study plans, conduct pharmacology studies, meet timelines, actively engage with global R&D stakeholders, and deliver high-value products. **Essential Job Responsibilities:** This position directly impacts our ability to prosecute our company goals of maintaining an early-stage pipeline of potential drug candidates. The measures of success are the advancement of new targets through the successive stages of the drug discovery pipeline. Their components are: + **Pipeline Advancement:** Contribute to the strategic expansion of Astellas' oncology pipeline by identifying promising drug targets and ensuring robust preclinical validation aligned with clinical development strategies. + **Strategic Program Leadership:** Conceive and manage oncology-focused drug discovery programs from early concept through preclinical development. Collaborate across multi-disciplinary teams including biology, chemistry, translational science, and clinical development to align scientific goals with strategic business objectives. + **Scientific Innovation & Execution:** Design and execute research studies that identify and validate therapeutic targets across a range of cancer indications focusing on GI & GU. Apply cutting-edge techniques in molecular biology, cellular assays, and in vivo models to support candidate selection. + **Data Analysis & Communication:** Utilize advanced analytical tools to interpret complex biological datasets, derive actionable insights, and present findings to cross-functional stakeholders and leadership. + **Cancer Biology Expertise:** Develop deep understanding of tumor biology, resistance mechanisms, and biomarker development. Focus on emerging areas such as targeted protein degradation, synthetic lethality, or immune-oncology strategies to enhance therapeutic efficacy. + **Collaboration:** Proactively foster strategic partnerships with leading academic institutions, clinical research centers, and biotech companies to accelerate the discovery of transformative cancer therapies. **Qualifications** **Required:** + Master's degree (MS) or Doctor of Philosophy (PhD) in relevant scientific field that provides knowledge of theories, principles and concepts within biological sciences or similar discipline. -MS with minimum 8+ years of drug discovery experience -PhD with minimum 5+ years of drug discovery experience + Proven expertise in molecular biology, biochemistry etc. with competence in designing, developing, and executing wide range of in vitro assays and/or in vivo animal models. + Exceptional understanding of mechanisms of cancer maintenance and key signaling pathways in the disease. + Experience with advanced molecular biology techniques including CRISPR/Cas9 gene editing, flow cytometry, and cell culture of both, primary tumor cells and established tumor cell lines. + Excellent problem-solving skills and the ability to design and execute hypothesis-driven research projects independently. + Effective communication skills, with the ability to present complex scientific data clearly to both technical and non-technical audiences. + Strong collaborative capabilities, with experience working in multidisciplinary teams to achieve common research goals. + Strong organizational, time management, and problem-solving skills with the ability to manage multiple projects and meet deadlines effectively. + Able to work productively and to participate in a highly creative and fast-paced environment. + Excellent communication and interpersonal skills. **Preferred:** + Strong track record of research productivity as evidenced by high-quality, impactful publications. + Experience working with small molecules. + Proficiency in evaluating cell signaling. + Attention to details with excellent organizational and record keeping skills. **Working Environment:** + This position is based in Cambridge US, MA and will require on-site work 5 days/week. **Salary Range** : $103,600-$162,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Cancer Biology Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
    $103.6k-162.8k yearly 28d 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. 10d 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
  • Scientist

    Frontage Lab 3.9company rating

    Hayward, CA jobs

    Title: Scientist Reports To: Group Leader Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant growth. Our core competencies include pre-clinical, 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. Position/Job Summary We are seeking a highly motivated and experienced Scientist specializing in LC-MS/MS to join our dynamic team. This individual will play a pivotal role in quantitative bioanalysis and the characterization and identification of drug metabolites, contributing to our understanding of DMPK (Drug Metabolism and Pharmacokinetics) and its impact on drug safety and efficacy. Roles & Responsibilities * Develop and optimize sample preparation and analytical methodology for quantitative measurement of drugs in a variety of modalities and metabolite profiling/identification using state-of-the-art LC-MS/MS and high-resolution mass spectrometry (HRMS). * Lead and execute LC-MS/MS-based projects in a timely and high-quality manner.Interact with clients to provide actionable insights on method development and sample analysis-related challenges. * Operate, maintain, and troubleshooting LC-MS/MS instruments; serve as instrument lead as needed. * Prepare and review scientific reports, presentations, and regulatory documents to ensure accuracy and compliance with industry standards. * Stay updated on advancements in LC-MS/MS technologies and methodologies. * Collaborate with cross-functional teams and provide technical guidance when needed. * Mentor and train junior lab staff. Education, Experience & Skills Required * Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. * Solid hands-on experience with LC-MS/MS-based bioanalytical method development including sample preparation, instrument operation and data processing. * Proven track record operating LC-MS/MS systems in a bioanalytical lab * Strong expertise in drug metabolism and biotransformation, with hands-on experience in metabolite identification using LC-MS/MS and HRMS. * Demonstrated ability to analyze and interpret complex mass spectrometry data and provide detailed reports. * Excellent communication skills and ability to work both independently and collaboratively in a cross-functional team environment. * Experience in pharma or biotech environment is a plus Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc 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.
    $95k-152k yearly est. 33d ago
  • Scientist

    Frontage Laboratories 3.9company rating

    Hayward, CA jobs

    Job Description Title: Scientist Reports To: Group Leader Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant growth. Our core competencies include pre-clinical, 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. Position/Job Summary We are seeking a highly motivated and experienced Scientist specializing in LC-MS/MS to join our dynamic team. This individual will play a pivotal role in quantitative bioanalysis and the characterization and identification of drug metabolites, contributing to our understanding of DMPK (Drug Metabolism and Pharmacokinetics) and its impact on drug safety and efficacy. Roles & Responsibilities Develop and optimize sample preparation and analytical methodology for quantitative measurement of drugs in a variety of modalities and metabolite profiling/identification using state-of-the-art LC-MS/MS and high-resolution mass spectrometry (HRMS). Lead and execute LC-MS/MS-based projects in a timely and high-quality manner.Interact with clients to provide actionable insights on method development and sample analysis-related challenges. Operate, maintain, and troubleshooting LC-MS/MS instruments; serve as instrument lead as needed. Prepare and review scientific reports, presentations, and regulatory documents to ensure accuracy and compliance with industry standards. Stay updated on advancements in LC-MS/MS technologies and methodologies. Collaborate with cross-functional teams and provide technical guidance when needed. Mentor and train junior lab staff. Education, Experience & Skills Required Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. Solid hands-on experience with LC-MS/MS-based bioanalytical method development including sample preparation, instrument operation and data processing. Proven track record operating LC-MS/MS systems in a bioanalytical lab Strong expertise in drug metabolism and biotransformation, with hands-on experience in metabolite identification using LC-MS/MS and HRMS. Demonstrated ability to analyze and interpret complex mass spectrometry data and provide detailed reports. Excellent communication skills and ability to work both independently and collaboratively in a cross-functional team environment. Experience in pharma or biotech environment is a plus Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc 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.
    $95k-152k yearly est. 30d ago
  • Scientist

    Frontage Laboratories 3.9company rating

    Hayward, CA jobs

    Title: Scientist Reports To: Group Leader Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant growth. Our core competencies include pre-clinical, 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. Position/Job Summary We are seeking a highly motivated and experienced Scientist specializing in LC-MS/MS to join our dynamic team. This individual will play a pivotal role in quantitative bioanalysis and the characterization and identification of drug metabolites, contributing to our understanding of DMPK (Drug Metabolism and Pharmacokinetics) and its impact on drug safety and efficacy. Roles & Responsibilities Develop and optimize sample preparation and analytical methodology for quantitative measurement of drugs in a variety of modalities and metabolite profiling/identification using state-of-the-art LC-MS/MS and high-resolution mass spectrometry (HRMS). Lead and execute LC-MS/MS-based projects in a timely and high-quality manner.Interact with clients to provide actionable insights on method development and sample analysis-related challenges. Operate, maintain, and troubleshooting LC-MS/MS instruments; serve as instrument lead as needed. Prepare and review scientific reports, presentations, and regulatory documents to ensure accuracy and compliance with industry standards. Stay updated on advancements in LC-MS/MS technologies and methodologies. Collaborate with cross-functional teams and provide technical guidance when needed. Mentor and train junior lab staff. Education, Experience & Skills Required Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. Solid hands-on experience with LC-MS/MS-based bioanalytical method development including sample preparation, instrument operation and data processing. Proven track record operating LC-MS/MS systems in a bioanalytical lab Strong expertise in drug metabolism and biotransformation, with hands-on experience in metabolite identification using LC-MS/MS and HRMS. Demonstrated ability to analyze and interpret complex mass spectrometry data and provide detailed reports. Excellent communication skills and ability to work both independently and collaboratively in a cross-functional team environment. Experience in pharma or biotech environment is a plus Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc 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.
    $95k-152k yearly est. Auto-Apply 60d+ 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 II, Discovery, Targeted Therapy

    Astellas Pharma 4.9company rating

    Cambridge, MA jobs

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Discovery Targeted Therapy Research team at Astellas is seeking a highly accomplished and visionary scientist to drive innovative research initiatives in oncology drug discovery. This role is ideal for a candidate who has a proven track record of successfully designing, executing, and leading discovery-phase research programs targeting cancer biology. The candidate will be responsible for being a member of a research program team to generate new ideas, develop study plans, conduct pharmacology studies, meet timelines, actively engage with global R&D stakeholders, and deliver high-value products. Essential Job Responsibilities: This position directly impacts our ability to prosecute our company goals of maintaining an early-stage pipeline of potential drug candidates. The measures of success are the advancement of new targets through the successive stages of the drug discovery pipeline. Their components are: Pipeline Advancement: Contribute to the strategic expansion of Astellas' oncology pipeline by identifying promising drug targets and ensuring robust preclinical validation aligned with clinical development strategies. Strategic Program Leadership: Conceive and manage oncology-focused drug discovery programs from early concept through preclinical development. Collaborate across multi-disciplinary teams including biology, chemistry, translational science, and clinical development to align scientific goals with strategic business objectives. Scientific Innovation & Execution: Design and execute research studies that identify and validate therapeutic targets across a range of cancer indications focusing on GI & GU. Apply cutting-edge techniques in molecular biology, cellular assays, and in vivo models to support candidate selection. Data Analysis & Communication: Utilize advanced analytical tools to interpret complex biological datasets, derive actionable insights, and present findings to cross-functional stakeholders and leadership. Cancer Biology Expertise: Develop deep understanding of tumor biology, resistance mechanisms, and biomarker development. Focus on emerging areas such as targeted protein degradation, synthetic lethality, or immune-oncology strategies to enhance therapeutic efficacy. Collaboration: Proactively foster strategic partnerships with leading academic institutions, clinical research centers, and biotech companies to accelerate the discovery of transformative cancer therapies.
    $66k-96k yearly est. 58m ago
  • Process Development Associate II

    AGC Biologics 3.6company rating

    Bothell, WA jobs

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Job Summary We are looking for a Process Development Associate II to join our Analytical and Formulation Development (AFD) team. AFD develops robust analytical methods to support drug release testing, upstream and downstream development, and non-GMP studies. The team also provides molecular characterization and scientific expertise for deviation investigations. In this role, you'll focus on executing analytical methods - primarily HPLC/UHPLC and capillary electrophoresis (CE-SDS, ic IEF)-to support process development activities. You'll work closely with experienced scientists, contribute to method optimization, and help drive continuous improvement projects within the department. This position is a great fit for someone who enjoys hands-on lab work, collaborating with teammates, and learning in a supportive environment. Location: Bothell, WA Schedule: Monday through Friday, onsite Compensation Range: $66,960 - $92,070 Essential Job Duties / Responsibilities Perform analytical testing in support of process development following established protocols. Assist in the development and optimization of analytical methods. Support method transfer to Quality Control. Coordinate and perform instrument maintenance and troubleshooting. Ensure accurate and complete documentation of results. Author, review, and edit analytical protocols and reports. Contribute to laboratory operations and continuous improvement efforts. Leadership Skills Communicates clearly and effectively with colleagues and customers. Solves straightforward problems and explains logic and decisions to others. Collaborates with teammates to support project and department goals. Qualifications BS/BA degree in biochemistry, protein chemistry, or related field, plus 2+ years of experience in an analytical lab. Required: Experience in chromatography (HPLC/UHPLC), preferably across multiple modes (SEC, IEX, RP, affinity). Preferred: Experience with capillary electrophoresis (CE-SDS, ic IEF). Strong interpersonal and teamwork skills; able to thrive in a fast-paced environment. Ability to adapt quickly to changing priorities or technical challenges. Strong data management skills and attention to detail in documentation and execution. Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit *************** W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
    $67k-92.1k yearly Auto-Apply 58d ago
  • Small Molecule Bioanalysis Scientist

    Medpace 4.5company rating

    Cincinnati, OH jobs

    Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Analytical Chemistry Scientist to join our Bioanalytical Lab team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Responsibilities * Develop and validate LC-MS/MS, GC-MS, ICP-MS, HPLC methods for small molecule drugs or drug metabolites and biomarkers; * Draft study protocols/plans, acquisition methods, and study reports; * Supervise all phases of bioassays to support pre-clinical and clinical pharmacokinetics, PD Biomarkers; * Supervise technicians for performing method development, validation, and sample analysis; * Communicate with internal and external resources for sample receiving, quality control, quality assurance, sponsor correspondence etc. Qualifications * PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field; * Previous experience with small molecule drug and drug metabolites analysis; * Strong project management, compliance, communication, and people skills; * Experience with various extraction procedures, such as LLE, SPE, SLE+, immune-capture hybrid extraction, etc.; * Experience with LC-MS/MS, GC-MS, ICP-MS, HPLC, etc.; * Direct working experience in Good Laboratory Practices is preferred. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $59k-86k yearly est. Auto-Apply 50d ago
  • Process Development, Associate Director - Cell Line Development (CLD), Biologics

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Boston, MA jobs

    Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics. The successful candidate will bring deep technical knowledge in cell line development and act as the technical lead for CLD work. This is a highly cross-functional role that will work closely with drug substance development, analytical development, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making. Key Duties and Responsibilities: * Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities. * Evaluate, select and manage external capabilities for cell line development. * Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies. * Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation. * Develop and manage project timelines and budget for CLD activites. * Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals. * Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer. * Review and approve technical protocols, development reports, and data packages provided by CDMOs. * Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners. * Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD. * Serve as a subject matter expert in regulatory agency interactions, audits, and inspections. * Expected travel: 10-20% (domestic and international) Required Education: * PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience. * Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered. Required Experience and Skills: * Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins. * Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred. * Knowledge of upstream process development and analytical methods related to CLD. * Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows. * Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.). * Proven track record of delivering on complex biologics development programs. * Excellent interpersonal, communication, and organizational skills. * Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment. #LI-LE1 Pay Range: $166,800 - $250,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
    $73k-88k yearly est. Auto-Apply 42d ago
  • Scientist I

    The U.S. Pharmacopeial Convention (USP 4.8company rating

    Rockville, MD jobs

    **Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **Brief Job Overview** This is a hands-on, non-supervisory position in USP's Reference Standards Laboratory. The Scientist I will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. A Scientist I has mastered many common techniques in the laboratory and is able to contribute their own observations and input to difficult projects. The incumbent will provide technical assistance to collaborative testing and the continued suitability for use program by performing analytical tests, reviewing analytical data, and preparing summary reports. The incumbent may execute 90% - 100% of their work at the bench level. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The **Scientist I** has the following responsibilities: + Demonstrates solid scientific approach to analysis in the laboratory. + Routinely applies personal experience, academic training, and technical insights - including emerging sciences - to solve complex technical problems within the laboratory. + Conducts analysis of reference standard candidates using a broad range of analytical methodologies. + Organizes, implements, and evaluates testing of reference standards materials. + Records experimental data, ensuring clear and accurate transcription of results and calculations. + Reviews literature for analytical test methods, as well as interprets and evaluates data. + Executes all testing and analysis of data with excellence and essentially no errors. + Demonstrates a strong desire to continue learning and grow personal capability. + Pursues, recommends, and implements new approaches or processes to improve laboratory operations. + Positively influences project direction by ensuring their own work is congruent with overall direction of laboratory projects. + Assists with other testing programs and duties in the laboratory as needed. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + B.A. /B.S. in Science and 2 years of relevant laboratory experience. + Working knowledge of common analytical methods and procedures [examples include: Infrared Spectroscopy (IR), Ultraviolet Spectroscopy (UV), Chromatography (TLC, HPLC, GC)], and expertise in calibrating and operating analytical instruments are required. + Extensive understanding of chromatographic analyses, as well as other general analytical chemistry principles required. **Additional Desired Preferences** + Strong communication and presentation skills, both verbal and written. + Experience working in the pharmaceutical and/or biotechnology industry is strongly preferred. + Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred. + Proficiency with electronic documentation systems is strongly preferred. + Takes personal responsibility to ensure work is delivered on time and is the highest possible quality. + Skills to anticipate, troubleshoot, and solve technical problems. **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Salary Range: USD $58,000.00 - $74,000.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Chemistry & Scientific Standards **Job Type** Full-Time
    $58k-74k yearly 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
  • 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
  • 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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