Scientist Jobs At Boehringer Ingelheim

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, Good Manufacturing Practices (GMP) manufacturing and stability storage and testing as well as Clinical Supply Services. Catalent Pharma Solutions is hiring a Principal Scientist for Product Development at our San Diego, CA site. An individual at the level of Principal Scientist, Product Development will lead projects as an individual or build a team focused on oral formulation development for small molecule or peptide drug products and amorphous intermediates. This individual may be required to have direct reports depending on growth and ability. The primary formulation platforms will include tablets, capsules, granules, beads, solutions, suspensions, immediate release and extended-release dosage forms, and amorphous intermediates. The individual will research and introduce new formulation technology to produce and characterize drug products and will be the primary point of customer contact for formulation strategy, compliance, and troubleshooting. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate. This is a full-time position: Monday - Friday, 8am-5pm on-site with flexibility for periodic remote/hybrid work. The Role: Creates and develops innovative drug formulations and has depth of experience in one or more of the techniques described above. Performs and trains others on a variety of formulation techniques including, but not necessarily limited to: blending, encapsulation, suspensions, solutions, wet/dry/fluid bed granulation, tablet compression, coating, milling, spray drying. Responsible for the successful transfer of formulation projects to the GMP manufacturing team and for collaboration with process engineering team during technology transfer. Communicates results both internally and externally through oral and written updates and formal reports as necessary. Organize meetings and monitor all client interactions independently. Participate in and lead cross-functional teams. Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent's services and will evaluate new technologies to expand our technical service offering. Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision. Hire, train, and supervise formulation group members as necessary. Develop junior personnel for advancement within the team. Participate in business development and marketing activities by generating scientific expert content, hosting new client visits or teleconferences, and attending conferences or client visits to generate new leads. Other duties as assigned. The Candidate: 4-year degree (Bachelor's/B.S.) in a physical, chemical, biological, or pharmaceutical science required plus a minimum of eight years of oral formulation development experience. We will also consider candidates who have a Master of Science (M.S.) with six years' experience, or PhD with four years of experience in oral formulation development. Must have managed at least 1-2 people in the past. Must have oral formulation development experience (Tablets, capsules, granulation experience required). Strong preference for early phase development (preclinical, phase 1, and phase 2 with new chemicals/small molecules). Experience in a client-facing role is a plus, but not a must-have. Demonstrable leadership experience at Catalent may be considered in place of external experience. Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 25 pounds. Pay: The anticipated salary range for this role in San Diego, CA is $145,000 - $170,000 annually. Why you should join Catalent: Awesome employee activities. Environmentally friendly green initiatives. Defined career path and annual performance review. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. 152 hours of PTO + 10 paid holidays. Positive and fast-paced working environment. Tuition Reimbursement. WellHub program to promote overall physical wellness. Perkspot - offers exclusive discounts. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email. #J-18808-Ljbffr

Principal Scientist 1, In Vitro Pharmacology Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. Join our team as we transform the lives of others. Position Summary: We are seeking a highly motivated and collaborative Principal Scientist 1 with experience in GPCR pharmacology and drug discovery to join our growing and dynamic Biology team. A successful candidate will be responsible for providing in vitro pharmacology support for lead optimization campaigns, mechanism of action studies, and new target efforts in endocrinology. Essential Job Functions and Responsibilities: Lead and manage a small team of junior scientists, promoting collaboration, efficiency, and innovative science. Design, develop, validate, and execute in vitro assays that support drug discovery programs. Conduct critical analysis and interpret data into a meaningful understanding of small molecule ligand activity and mechanism of action. Demonstrate a high level of initiative to oversee, troubleshoot, and accurately perform data analysis in an environment that values scientific integrity and quality. Conduct resource management to deliver critical in vitro pharmacology data to support multiple programs simultaneously. Lead and/or provide in vitro pharmacology leadership role on cross-functional program teams. Interpret and demonstrate effective written and oral communication of results to interdisciplinary teams. Participate in the strategic planning of departmental growth and organization. Lead external collaborations and outsourced studies. Identify and evaluate new research targets within therapeutic areas of interest. Author scientific publications and prepare technical reports to support regulatory submissions. Ensure compliance with company-established practices and procedures, including laboratory notebooks, computer files, quality and regulatory guidelines, and safety standards. Education and Experience: Required: Ph.D. in Pharmacology, Biochemistry, Biology, or related discipline with at least 8 years of relevant experience. Applicants with a bachelor's degree must demonstrate a minimum of 15 years and those with a master's degree must demonstrate 13 years of significant and relevant experience. At least 7 years of experience with drug discovery and small molecule pharmacology in therapeutically relevant GPCRs or related fields. Demonstrated technical proficiency in biochemical, cellular, and/or radioligand binding assay systems. Ability to independently determine in vitro pharmacologic methods and procedures to achieve Program goals. Outstanding experimental design, problem-solving, and data analysis skills. Demonstrated practical experience and deep understanding of in vitro pharmacological theory, models, mechanisms, and experimental design, particularly with GPCRs. Must be independent and able to follow pre-established experimental designs, as well as develop new methods, protocols, and technologies based on existing literature. Strong work ethic and enthusiasm for a mix of laboratory work and management in a dynamic environment. Strong communication skills and the ability to work closely and effectively in a multidisciplinary team environment. Experience in management and daily supervision of scientific staff is highly preferred. Experience in program management/leadership desired. Strong written and verbal communication skills. Experience with writing reports and technical regulatory documents. Must be detail-oriented, punctual, and reliable. Ability to work in a fast-paced environment and adapt to change. Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. Laboratory Activities: Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: $148,000 - $185,000 In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Vaccination requirement: Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. #J-18808-Ljbffr

Title: (Senior) Scientist, Cardiovascular Diseases Salary: $125,000-$145,000 EPM is currently partnered with clinical stage biopharmaceutical company with an exciting pipeline that shows preclinical promise in a broad range of clinical indications. Two lead assets are currently in early phase clinical developments, and on track for further clinical development this year. The leadership team brings over 25 years of success, with FDA-approved therapies, IPO launches, and multiple strategic biotech exits, along with deep connections across life sciences and venture ecosystems. Backed with resourceful funding and high-value partnerships in biotech and top-10 pharma, the company is well-positioned to reinvest into R&D, while advancing their current clinical pipeline in CNS and Fibrotic indications. They have identified that their platform naturally aligns with cardiovascular biology and are expanding into this area to drive the next wave of first-in-class therapies Key Responsibilities: Lead target discovery, identification, and validation efforts focused on cardiovascular and cardiometabolic diseases, leveraging a cutting-edge small molecule discovery platform. Design and execute in vitro and cell-based assays to interrogate target biology, disease-relevant pathways, and compound activity across cardiovascular indications (e.g., atherosclerosis, vascular remodeling, heart failure, and fibrosis). Collaborate cross-functionally with chemistry, translational, and clinical teams to ensure alignment between discovery biology and downstream development strategies. Apply deep knowledge of vascular biology, endothelial dysfunction, inflammation, and metabolic signaling to guide biological validation of new targets. Analyze and interpret complex data sets, integrating findings into broader disease biology and drug discovery programs. Contribute to the development of the cardiovascular research strategy, incorporating new technologies, disease models, and biomarker approaches to support target prioritization and lead optimization. Stay current with emerging science and competitive landscape in cardiovascular and cardiometabolic drug discovery, providing scientific insights to shape pipeline expansion. Key Skills & Qualifications: PhD in Cardiovascular Biology, Vascular Biology, Pharmacology, or a related discipline, with 3+ years of relevant industry experience(open to strong postdocs looking to transition). Deep expertise in cardiovascular disease biology, including knowledge of vascular dysfunction, endothelial biology, cardiomyocyte biology, cardiac fibrosis, and metabolic signaling. Hands-on experience with target discovery techniques such as: CRISPR screening RNA sequencing & omics data interpretation Biochemical and cellular assays to study target function (reporter assays, phenotypic screening, pathway modulation). Strong foundation in in vitro pharmacology- assay development, compound profiling, and mechanism-of-action studies for small molecules. Ability to work in a highly collaborative environment, communicating effectively with medicinal chemists, translational biologists, and external partners. Experience working within a small to mid-sized biotech environment is a plus - comfort operating in a fast-paced, evolving R&D setting. Passion for cardiovascular discovery and desire to play a hands-on role in shaping pipeline strategy in an innovative biotech setting.

Summary: The R&D Formulator develops and optimizes formulations, conducts testing, and ensures accurate documentation. Supports technology transfer, collaborates cross-functionally, and stays updated on industry trends. Maintains lab safety, mentors staff and participates in management meetings. Evaluates raw materials, improves formulations, and oversees special projects as assigned. Essential Duties and Responsibilities Formulation creation (bench mix, formulation sheet, product description sheet, sample measurement, color verification, etc.) Writes and/or reviews procedures, purchase orders, quotes, and specifications needed to support product development activities Develops and/or performs all formulation requirements on new formulas Documents test results, specifications, and final formula procedures in a standard format for inclusion in the master file Participates in the technology transfer from pilot scale to manufacturing Communicates, in a timely fashion, all information regarding formulation, project status, raw material research, results, etc. to all appropriate individuals in Purchasing, Sales, Customer Services, and Quality departments Conducts intellectual searches for technical information through a variety of resources Keeps abreast of current trends, practices, developments, and regulatory changes, which would impact products, procedures, or formulation Ensures the maintenance and/or adherence to good laboratory practices and all safety regulations both in laboratory and manufacturing areas Provides technical knowledge in guiding other assistants/technicians in the R&D Lab Develops and presents to the R&D Manager or Director, R&D matters requiring his/her decision Participates in scheduled Management and Sales meetings in the absence of the R&D Manager/Director Evaluate new and alternative raw materials for functionality and stability Assist in verification studies as required Reformulate to improve existing products as needed Special projects as needed and any other tasks assigned by the R&D Director or Manager. Qualifications/Education/Experience: Minimum Bachelor of Science in Chemistry or related field 2+ years' Experience in R&D, Quality Assurance, Quality Control or Manufacturing is required; nutritional, pharmaceutical or biotechnology experience preferred; Have strong eye for color, finish, and detail Must have proficient math skills; weights and volumes experience a plus Excellent communications (verbal/written) Excellent organizational and multi-tasking skills Proficient with MS Word, Excel, Teams, and Outlook Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes, or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.

Title: Analytical Scientist About the Company Are you passionate about groundbreaking science and innovative healthcare solutions? We are a rapidly growing, well-funded biotech company with a hybrid platform that combines both innovative and specialty products. Our mission is to revolutionize the biotech industry by developing cutting-edge therapies and specialty products that address unmet medical needs. Job Description As an Analytical Scientist, you will play a crucial role in our research and development efforts. You will be responsible for developing and validating analytical methods from scratch, ensuring compliance with Good Manufacturing Practices (GMP), and utilizing advanced analytical techniques to support our projects. Key Responsibilities Develop and validate analytical methods independently. Perform routine and non-routine analysis using techniques such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and UV-Visible Spectroscopy (UV-Vis). Ensure all work complies with GMP regulations and standards. Troubleshoot and optimize analytical methods and instrumentation. Document and report analytical data accurately and promptly. Collaborate with cross-functional teams to support product development and quality control. Maintain and calibrate analytical instruments and equipment. Qualifications Bachelor's, Master's, or Ph.D. in Chemistry, Analytical Chemistry, or a related field with minimum 2 years GMP industry experience. Proven experience in developing analytical methods from scratch. Strong knowledge of GMP regulations and practices. Proficiency in using HPLC, MS, and UV-Vis techniques. Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Ability to work independently and manage multiple projects simultaneously. Benefits Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and inclusive enviornment

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. What will you do? Responsible for developing innovation technologies and Taste solutions in the area of reaction flavors (Maillard reaction), contributing to the growth objectives of the Global Taste Innovation Platforms. Expertise in Maillard reactions, with focus on thermal generation of flavors, comprehensive understanding of interactions between reducing sugars with amino acids. Research experience of reaction chemistry within the flavor categories of: savory, dairy, brown tonalities and taste modulation. Work on global projects, delivering results against technology gaps and needs in Kerry by collaborating closely with key stakeholders and partnering departments including regional Flavorist technology champions, RD&A Scientists and Technologists, Portfolio Manager, Marketing, Sensory, End use market business teams, Operation, and Regulatory. What will you need to be successful? Bachelor's of Science with 10+ years of experience, Master of Science with 6+ years of experience or Ph.D. with 4+ years in organic chemistry or analytical chemistry or food chemistry, chemical Engineering or related science. Strong research track record in reaction flavors, Maillard chemistry, and relevant analytical skills. Analytical skills for gas chromatographic systems with several detectors as FID, pFPD, MSD, and MSMS; GCO for characterization of key Savoury and smoke aroma components and off notes. Expertise in Maillard chemistry, ability to explain mechanisms; Need for skills that can decipher competitive complex flavors, reaction notes, characterize top notes, as well as work closely with flavorist and culinary teams. Create methods that are more sensitive Development of methods for the generation and detection of important intermediates using Py/GC/MS, HPLC, FTIR and other analytical techniques. Structural elucidation of reaction mechanisms using 13C- and 15N-labeled reactants is one of the main objectives of the research program. Compensation Data The typical hiring range for this role is $91,311 to $134,638 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov). Beware of scams online or from individuals claiming to represent us. A Kerry employee will not solicit candidates through a non-Kerry email address or phone number. In addition, Kerry does not currently utilise video chat rooms (e.g., Google Hangouts) to conduct interviews. Refuse any request that asks you to provide payment to participate in the hiring process (e.g., purchasing a “starter kit,” investing in training, or something similar). Kerry will not ask you to pay any money at any point in the hiring process with the exception of reimbursable travel expenses. In addition, any payments made by Kerry will be from official firm accounts bearing the Kerry name.

Florida Job Description: As an Analytical Scientist, you will play a crucial role in our research and development efforts. You will be responsible for developing and validating analytical methods from scratch, ensuring compliance with Good Manufacturing Practices (GMP), and utilizing advanced analytical techniques to support our projects. Key Responsibilities: Develop and validate analytical methods independently. Perform routine and non-routine analysis using techniques such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and UV-Visible Spectroscopy (UV-Vis). Ensure all work complies with GMP regulations and standards. Troubleshoot and optimize analytical methods and instrumentation. Document and report analytical data accurately and promptly. Collaborate with cross-functional teams to support product development and quality control. Maintain and calibrate analytical instruments and equipment. Qualifications: Bachelor's, Master's, or Ph.D. in Chemistry, Analytical Chemistry, or a related field with minimum 2 years GMP industry experience. Proven experience in developing analytical methods from scratch. Strong knowledge of GMP regulations and practices. Proficiency in using HPLC, MS, and UV-Vis techniques. Excellent problem-solving skills and attention to detail. Strong communication and teamwork abilities. Ability to work independently and manage multiple projects simultaneously. Benefits: Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and inclusive work environment. Cutting-edge laboratory facilities and resources.

What the Senior Scientist in Biomarker Analysis does at Worldwide As a Senior Scientist in Biomarker Analysis, you will be a key contributor to our bioanalytical team. Your role involves method development, validation, and sample analysis for ligand binding assays. You'll work closely with the supervisor to ensure accurate and efficient execution of bioanalytical processes. If you're passionate about advancing bioanalysis research and have a strong foundation in bioanalysis, this role is for you. What you will do Involve efficiently manage biomarker research projects from initiation to completion. Help project manager to ensure adherence to project timelines and budget constraints. Collaborate with cross-functional teams to achieve project goals. Engage with clients to understand their requirements, expectations, and feedback. Maintain effective communication channels throughout the project lifecycle. Provide troubleshoot for junior team member: troubleshoot experiments and address any technical challenges promptly. Optimize processes to enhance efficiency and data quality. Work closely with QA/QC teams to maintain high-quality standards. Ensure compliance with relevant regulations and guidelines. Manage project-related documentation. Review scientific literature to understand existing methods for detecting and quantifying biomarkers. Explore studies related to biomarker concentrations and their relevance in various diseases. Formulate a comprehensive strategy for biomarker testing across different platforms. Consider using techniques like MSD (Meso Scale Discovery) and PCR (Polymerase Chain Reaction). Ensures Inspection Readiness for risk assessment and centralized monitoring scope. What you will bring to the role Proficient in MSD, ELISA, and PCR is a plus. Experienced in LIM system is a plus. Strong analytical skills and attention to detail. Proficiency in general laboratory practices and techniques. Ability to work independently and as part of a team. Ability to read, execute, and understand complicated and detailed instruction and technical literature to plan, perform, and direct laboratory activities. Must be able to work well with a variety of laboratory personnel. Strong written and oral communication skills Basic computer knowledge Your experience Education: minimal request: bachelor's degree in a scientific discipline (Immunology, molecular biology, biochemistry, or related field). Master's degree and Ph.D. are plus. Experience: minimal request: bachelor's degree with a minimum of 10 years of direct laboratory experience. Master's degree with 5 year of direct laboratory experience. BSc/RN or equivalent combination of knowledge, skills and experience

Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of sustainable nutrition. A career with Kerry offers you an opportunity to shape the future of food while providing you opportunities to explore and grow in a truly global environment. About the role Plays a key role in the profit enhancement and business growth of Kettle. Supports RD&A with analyses, tests, and experimental designs at the manufacturing level. Will be based in Ft. Worth (manufacturing facility),and work closely with production and corporate R&D teams to scale up items. Responsible for implementing trials successfully to drive business growth through formulation and process improvements. What will you do? Work with team to design and conduct research including new product research and the development of foods. Work with Sales, RD&A and Culinary teams to field customer requests both internal and external to satisfy project needs from a conceptual phase through troubleshooting and commercialization. Work with cross functional groups to optimize the strengths of Kerry and deliver the best Taste and Nutrition experience for our customers What will you need to be successful? BS/MS/PhD in Food Science/related science field. Strong background in food chemistry, sensory, microbiology, food packaging systems. Food engineering or product development expertise in related field. Core understanding of food safety and quality Demonstrated ability to work well on team projects Compensation Data The typical hiring range for this role is $75,602 to $111,475 annually and is based on several factors including but not limited to education, work experience, certifications, location, etc. In addition to your pay, Kerry offers benefits such as a comprehensive benefits package, incentive and recognition programs, equity stock purchase and retirement contribution (all benefits and incentives are subject to eligibility of the requirements). Kerry is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law. Kerry will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen. Additional information can be found at: Know Your Rights: Workplace Discrimination is Illegal (dol.gov).

Scientist/Senior Scientist - In Vitro Diagnostics (IVD) Test Development Reports To: Senior Director, IVD Test Development A growing team is looking for a Scientist/Senior Scientist with expertise in in vitro diagnostic (IVD) assay development to lead research projects, contribute to scientific innovation, and oversee Validation & Verification studies supporting PMA, 510K, and IVDR approvals. This position requires working within a regulated environment under design control, managing project timelines, analyzing data, and mentoring junior scientists. Additionally, the role may involve handling human biological specimens (blood, plasma, urine, and other bodily fluids) while ensuring compliance with safety regulations and organizational policies. Key Responsibilities: Oversee project studies that contribute to regulatory filings while effectively managing multiple unrelated projects. Design and refine study protocols, ensuring scientific rigor and compliance with CLSI guidelines and regulatory standards. Execute and document product development activities in alignment with design control procedures and quality management systems. Independently perform statistical analyses or collaborate with statisticians to evaluate data. Analyze and interpret experimental results, providing insights and determining next steps for project advancement. Ensure data accuracy and validity for internal reports, regulatory submissions, and scientific publications. Prepare comprehensive and well-structured study reports for regulatory documentation. Develop and deliver data-driven presentations to internal teams and external stakeholders. Lead technical discussions, drive project meetings, and ensure strategic alignment with company goals. Supervise and mentor junior scientists, fostering a culture of innovation and scientific excellence. Maintain compliance with safety guidelines, including biosafety and hazardous material handling protocols. Perform other duties as required. Required Qualifications & Experience: Education & Experience: Ph.D. in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 7-12 years of industry experience. Master's degree with 10-15 years of relevant experience. Bachelor's degree with 16-20 years of experience. Technical Expertise: Extensive experience in IVD product development, with strong knowledge of FDA and global regulatory requirements. Hands-on experience creating protocols and reports suitable for regulatory submission. Proficiency in statistical analysis software (Analyze-It, JMP). Experience in commercial IVD product development is preferred. Leadership & Analytical Abilities: Demonstrated ability to lead research teams and effectively manage multiple projects. Strong analytical and problem-solving skills, with expertise in data interpretation and statistical analysis. Ability to troubleshoot complex technical challenges and drive research forward. Communication & Collaboration: Proven experience in developing high-quality scientific reports, publications, and presentations. Excellent verbal and written communication skills, with confidence in presenting findings to diverse audiences. Strong interpersonal skills for mentorship and cross-functional collaboration.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $69,000 - $179,300. Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Summary: Lilly Oncology's Large Molecule Discovery team is looking for a Principal Scientist in Chemistry/Biochemistry to support our growing biologics portfolio. This role will support Antibody-drug conjugates (ADCs) linker and payload design, develop conjugation technologies, and downstream biochemical assays to enhance ADC biological and pharmacologic properties. We are looking for a strong scientist with good knowledge and hands-on experience in designing, preparing, and characterizing ADCs. This individual will be a self-motivated, responsible, and productive scientist who enjoys collaborating. He/she will be responsible for rigorous experimental design, data analysis, and data interpretation. This position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment. Responsibilities: Prepare, purify, and characterize the high-quality antibody-conjugates (ADCs, ARCs, DACs etc.) with a high degree of independence in support of discovery and development of programs. Implement state of the art bioconjugation technologies (cysteine, lysine, site-specific and other) and utilizing novel chemistries to generate bioconjugates. Experienced in development of purification strategies (up to 200 mg) with affinity, ion-exchange, hydrophobic interaction, size exclusion, and tangential flow filtration. Experienced in ADC characterization methods, including UV-Vis, SEC, HIC, RP, IEX, cIEF, and LC-MS. Maintain thorough documentation of experimental procedures in electronic notebook or database, writing of reports and technical documents. Maintain scientific and technical expertise through familiarity with scientific literature and attending conferences. Engagement with multidisciplinary project teams to design, execute, and interpret experiments. Demonstrated record of scientific accomplishments and publications. Participate and present periodic updates and reports to management team. Participate in long-term strategies for creation of innovative solutions and intellectual property for securing FTO for Lilly. Maintain a safe, pleasant, and efficient working environment. Basic Requirements: A minimum of a bachelor's degree in chemistry, Biochemistry, or other related scientific discipline with a record of minimum 4 years lab-based independent research experience is required. Advanced degree (Master's, Ph.D.) with 2+ years of relevant experience is preferred. Deep expertise in using state-of-the-art conjugation methods and handling of highly potency cytotoxic payloads. Additional Preferences: Strong hands-on experience producing and characterizing antibody and protein drug conjugates using HIC, SEC, LC-MS, IEX, and RP-HPLC. Experience with protein purification systems is preferred with hands-on experience and proficiency working with AKTA FPLCs. Must be highly collaborative and able to effectively engage small-molecule research project teams to make rapid progress. Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Ability to multi-task and shift priorities rapidly to meet tight deadlines. Excellent written and verbal communicator. Detail oriented and well organized. Enthusiastic, self-motivated, and keen to improve processes. Additional Information: Physical Demands/Travel: The physical demands of this job are consistent with a laboratory/bench environment. Some light lifting, and maneuvering may be required. Work Environment: This position's work environment is in a laboratory/bench environment. #J-18808-Ljbffr

What the Research Associate 1 does at Worldwide The Research Associate 1, has have familiarity with processing and reviewing clinical documentation, interacting with participants, and accommodating competing priorities in a dynamic clinical research environment. What you will do Conducts screening visits for participant recruitment into clinical trials under the supervision of the Screening Supervisor. Reviews study protocol and informed consent form for studies they are assigned to. Ensures electronic and paper source documents for the trial are accurate according to study specific protocol. Prepares and maintains study-specific screening documents and study folders. Responsible for reviewing the informed consent form, medical history, inclusion/exclusion criteria, and other study documents as required with participants to determine eligibility. Serves as primary contact for participants from screening through check-in for studies. Addresses all questions from participants related to study eligibility, study participation, and/or concerns What you will bring to the role Excellent written and oral communication skills. Ability to understand complex written and oral instructions. Excellent attention to detail resulting in high-quality work. Exceptional organizational skills. Ability to set and meet deadlines. Your experience Bachelor's Degree (preferably in the field of Life Sciences or Health). Six months or more experience in health care.

Research and Development ( R &D ) Chemist Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Research and Development ( R &D ) Chemist for immediate addition to our fast growing team. Job Description The R&D Chemist is responsible for all steps of formula development from ideation to final formulation. Primary responsibilities will be the innovation of new products, technology transfer and cost savings. He/she will demonstrate formulation and innovation skills in Personal Care, Cosmetics and Over-the-Counter products. The R&D Chemist will be proficient with analytical and numerical skills and able to perform basic mathematical calculations in various units of measurement and able to navigate concepts such as fractions, percentages, and ratios. He/she must have a strong attention to detail, capable of efficiently communicating verbally and through writing, produce and share reports, demonstrate excellent organizational skills be able to perform physically demanding activities such as moving and lifting equipment and standing for extended periods of time. Responsibilities Formulate product prototypes and evaluate them for chemical and physical properties, performance, and stability. Develop new formulations for different personal care products, cosmetics, and OTC's. Improve current product formulations. Research product formulations and properties of raw materials. Provide and prepare samples for biological laboratory and field testing for efficacy and safety. Initiate, develop, and create innovative products to expand the R&D formulation library and enhance customer presentations. Establish product specifications and procedures as required for R & D projects. Support scale-ups from prototype to commercial manufacture and following Good Manufacturing Practices (GMP). Support technical service for operations and consumer relations. Conduct research and field evaluations on new products. Develop new products and improve functioning of existing products. Provide technical assistance and supervisory support within laboratory, and documentation to Compounding, Production, Documentation, and Scheduling Departments. Coordinate research and development activities within all organizational departments. Develop reports and documents detailing project processes, results, and conclusions. Maintain accurate records, notebooks of analysis and work performed. Comply with all Tri-Pac Safety requirements, GMP/GLP, and customer requirements. Support scheduling and testing of R&D stability samples. Support shipping samples to external lab for testing. Maintain laboratory paperwork system according to GMP. Education And/or Experience BS or MS Degree in Chemistry or Biosciences or related degree Minimum 2 years' experience in cosmetic formulation/product development or related field. OTC/Drug formulation preferred. Must be familiar with basic cosmetic lab equipment including FTIR, viscometer, pH Meter, Moisture Analyzer, etc. HPLC and GC experience is desired. Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. ************** Thank you for your interest and consideration of a career with Tri-Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

Vertex is seeking an experienced scientist eager to help develop both cutting-edge small molecule as well as synthetic peptide and oligonucleotide-based pharmaceuticals and the science underpinning the analytical control of their syntheses. As a member of the Analytical Development team, this role will support drug development programs at Vertex with a focus on drug substance process and control strategy development for both small molecules and oligonucleotide-based therapies. Specifically, the individual will help design the tests and control strategy for novel drug substances, collaborate closely with associated CM&C functions, and act as a subject matter expert liaison with our global network of external drug substance manufacturing and development vendors. The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success. Key Duties and Responsibilities: Collaboratively design and oversee drug substance process development analytical activities across all phases of development, including late phase development following Quality by Design (QbD) principles. Serves as subject matter expert for setting and justifying drug substance, intermediates, and starting materials specifications with the understanding of clinical study design, supporting toxicology studies, and CMC processes. Identify critical in-process-control issues and develop appropriate IPC methods. Serve as the subject matter expert for drug substance analytical development with contract manufacturing and testing labs. Develop analytical methods, suitable for progressive stages of pharmaceutical development and/or supervise activities. Justify and set retest period, storage, and shipping conditions for starting materials and intermediates. Understand chemical development and solid-state development to identify and document critical factors that impact method performance and/or analytical development activities. Develop and review source documents for regulatory submissions. Present to cross functional teams and effectively communicate critical analytical issues and solutions. Knowledge and Skills: Excellent verbal and written communication skills are essential. Experience and/or working knowledge of control strategy development, spike/purge studies, drug substance QbD process development. Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines). Skilled in modern analyses for peptides, oligonucleotides, and/or small molecule pharmaceuticals, particularly chromatography. The ability to work successfully in both a team/matrix environment as well as independently. The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects. Education and Experience: Ph.D. with 4-7 years of relevant analytical development experience, particularly focused on development of novel drug substances. Exceptional candidates with MS or BS degrees and extensive high-level experience will also be considered. Background in, or good understanding of modern synthetic organic chemistry, as well as of the drug substance development process, process chemistry, and pharmaceutical manufacturing, and their interrelationship with analytical development. Hands-on experience in the analysis and familiarity with the control strategy of synthetic peptide and oligonucleotide-based pharmaceuticals. 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. 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. #J-18808-Ljbffr

Kelly Science & Clinical is seeking an ICP-MS Chemist for a contract-to-hire opportunity with one of our clients, a chemical manufacturing company in Portland, OR location. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Salary: $ 25-28/hour Workplace: Onsite Portland, OR Schedule: Monday-Friday 7am-4pm Overview Leads and supports to design chemical laboratory processes, tests, and analysis to ensure quality and safety, always keeping in mind our client's Operating Priorities of Safety, Quality, and Productivity. Responsibilities Set up laboratory equipment and instrumentation required for tests, research, or process control. Prepare chemical solutions for use in processing materials, following standardized formulas or experimental procedures. Test and analyze chemicals to determine purity. Document results of tests and analyses. Prepare and graph statistical information on data using ideas and tools associated with Statistical Process Control. Use them for process improvement and enhancement of detectability in the lab. Maintain inventory of laboratory. Participate in planning for lab activities. Lead training and development of Laboratory Assistants. Participate in developing new analysis methods on new or existing tools. Lead gauge Repeatability and Reproducibility studies. Lead MSA Studies Monitor and review equipment using statistical process control / Long Term Stability and take appropriate action for out-of-control situations according to response plans. Utilize ERP system to move product to next operation and notify plant of out-of-control product. Generate and execute ideas for quality and process improvements. Lead documentation of standard operating procedures Communicate with other company departments regarding quality issues and information being generated in the laboratory. Participate in the laboratory's close collaboration with production/production technical/quality assurance teams for department improvement activities. Qualifications Bachelor's degree in chemistry or closely related field from a four-year college or university. College level courses in statistics are desirable. 2-5 years of directly relevant work experience, preferably in a manufacturing environment, or an equivalent combination of education and experience. Computer/PC competency is essential. Must be proficient working in MS Office (especially Excel, Access, and Word). Experience utilizing statistical analysis programs preferred (JMP). What happens next: Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless. #P1

Havas Health Network is seeking an experienced Data Scientist to join their dynamic team in New York City. This role is ideal for someone with a robust background in analytics within the healthcare administrative claims domain, coupled with years of experience in coding and algorithm development. As a Data Scientist, you'll be instrumental in driving data-driven insights that support critical decision-making across various projects. This role is hybrid, 3 days per week in the office. We are unable to sponsor or do transfers for this role. No outside agencies. Core Responsibilities: Design, develop, and implement scalable data mining, machine learning, and graph algorithms based on business needs and across disparate data sets Work with stakeholders to develop automated and bespoke solutions that provide answers and insights derived from data Develop and manage data quality control processes across all data assets Take requirements from stakeholders and implement Articulate and share insights based on the data, coming through a marketing and commercial impact lens Create use cases around data to answer specific business questions Required Qualifications: Minimum of 5 years of experience in analytics or business intelligence, with knowledge of marketing analytics Proven ability to apply cutting-edge analytics techniques to solve business challenges and leverage external thinking from emerging technologies. Strong ability to translate data into insights that illuminate customer needs and behavioral drivers. Capable of providing points of view and showcasing expertise in advanced analytics techniques Able to articulate highly technical matters and share data insights to both technical and non-technical stakeholders Participating in new business pitches and representing analytics in these discussions. Implement process and organizational efficiency through automation. Demonstrated experience in analyzing healthcare administrative claims data, social media data, graph data, and time series data Experience in developing scalable algorithms for large (>1TB) datasets Demonstrated experience in leveraging relational, graph, and vector databases Experience in leveraging cloud computing resources to implement and deploy scalable algorithms Experience in developing software in a Linux environment Programming experience (5+ years): SQL, Cypher, Python, Python-Polars, Python-SciKitLearn Algorithms: clustering, machine learning, feature extraction, embeddings, graph-embeddings (GraphSage, FastRP, etc.) Experience in the following programming languages: Rust, Mojo Preferred Qualifications: PhD, BS or MS in any one of the following disciplines: Computer Science, Physics, the following engineering majors - Mechanical, Electrical, Chemical As the largest health advertising and communications organization in the world, we are focused on making a meaningful difference in brands, businesses and people. At Havas, we create ideas and experiences that change the way people think about wellness. With unmatched DNA across the health sector, we use the most innovative technology to turn creative ideas into meaningful outcomes.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description We are seeking a highly motivated and creative Scientist with a scientific background in immunology or immuno-oncology to join Precision Medicine Translational Research Immunology Group as Principal Scientist at AbbVie. The candidate will provide leadership in clinical biomarker strategy and assay development in inflammatory/autoimmune disease areas, including Dermatology, Gastroenterology, Rheumatology and Fibrosis for AbbVie's drug development programs from late discovery to clinical trials. The successful candidate will be part of a growing translational research group working with cross-disciplinary teams both internally and externally. Key Responsibilities: Lead biomarker strategies through cross-functional teams in a matrix environment to identify gaps and develop fit-for-purpose clinical TE/PD biomarker, predictive and exploratory biomarker assays to support human dose projection and establish early signs of efficacy in clinical trials and patient selection strategies. Collaborate with Data Science team and Precision Medicine lead to analyze internal and external omics data, understand heterogeneity of diseases, identify disease endotypes, support disease strategy and generate patient selection and combination hypotheses for further testing with preclinical studies. Develop preclinical patient derived disease models, design studies with appropriate controls and endpoints to understand drug target mechanisms for PD biomarker development and evaluate biomarker hypotheses and combination strategies. Serve as a subject matter expertise in analytical methodologies/technologies for translational research including single cell and spatial omics, proteomics, methylomics, metabolomics, genomics, NGS, MSD, ELISA, Luminex, flow cytometry, ex vivo primary cell culture and organoid-immune cell culture. Manage external CROs and academic collaborations including study proposal, budget, timeline, and data review. Manage and coach a team of translational scientists, ensuring the successful execution of translational research plans across multiple projects. Keep abreast of latest research & development in inflammatory and immune diseases through critically reviewing literature, attending conferences, and seeking advice from KOLs. Qualifications Major or advanced degree in Immunology, cell & molecular biology, pharmacology, pathology, bioinformatics or other relevant biological sciences. B.S. & typically 14+ years, M.S. & typically 12+ years, Ph.D., or equivalent & typically 8+ years of relevant industrial biotechnology experience. Experience in leading translational medicine in Rheumatological diseases (RA, SLE, SSc) is a plus. Expertise in a broad range of translational technologies, data analytics and computational tools. Proficient in multi-parameter flow cytometry, including spectral flow cytometry and analytical software (e.g., BD FACSDiva, Flowjo, OMIQ) to analyze different immune cell types and cell states from mice, human and cynomolgus monkey. Experienced in designing and conducting single cell omics, spatial omics, genomic-based assays and developing analytical workflow to generate or validate biomarker hypotheses. Knowledgeable with integrative analysis of multi-dimensional datasets using bioinformatics tools and methods (e.g., R, Python, SQL, AI/ML, HPC and cloud environments) Strong project leadership and organizational skills to prioritize tasks and allocate resources to meet projects' goals in a tight timeline. Experienced in managing CROs and collaborators, facilitating meetings, and working independently and collaboratively with multi-functional teams in a dynamic and fast paced environment. Demonstrated ability to supervise and coach direct reports. Excellent communication, presentation, organizational and people management skills Strong track-record of scientific publications from peer reviewed journals and presentations in major conferences Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* #J-18808-Ljbffr

AbbVie Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from clinical proof of concept through commercial product launch. We are a world-class team of scientists and leaders driving the advancement of industry-leading analytical capabilities and AbbVie's pipeline of innovative medicines. Careers in AbbVie Parenteral PDS&T provide opportunities to work with global and cross-functional teams to develop innovative products and drive exceptional science. Job Description The Analytical Development group within Parenteral PDS&T is responsible for biologics programs that are transitioning from development stage to optimization and commercialization. We lead final method development, optimization, and validation, ensuring all analytical methods are fit for use in commercial QC laboratories. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; stability studies to establish commercial product dating; and approvable marketing application submission content. We are looking for a highly motivated person with experience in analytical development for biologics products who can oversee laboratory activities supporting analytical method development, optimization, and validation. Key Responsibilities Provide leadership and talent development for a team of scientists responsible for a suite of late-stage biologics products including monoclonal antibodies, antibody drug conjugates, bispecific antibodies, etc. Lead the design and execution of experiments for method robustness and method validation studies. Demonstrate a critical mindset for method troubleshooting, examining data holistically, and guiding and advising scientists through protocol execution. Independently responsible for project activities within area of expertise while also contributing within the project team to the overall progress of the program. Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones. Effectively organize and present scientific plans and data. Author, review, and/or approve technical documents (e.g., methods, protocols, reports, etc.), scientific publications, presentations, and regulatory documents. Qualifications PhD (8+ years), Master's Degree (14+ years), or Bachelor's Degree (16+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience. Previous supervisory experience managing teams required. Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis (e.g., ic IEF, CE-SDS), and/or other separation techniques as applied to protein analysis is required. Practical experience with method validation and working in a GMP environment is required including designing studies, authoring protocols and reports, laboratory notebook documentation, etc. Experience with investigations, validation events, out of specification, or out of trend evaluations preferred. Familiarity with analytical Quality by Design (AQbD) preferred. Solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development, is preferred. Ability to multitask and work within timelines. Demonstrated scientific writing skills and strong verbal communication skills. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* #J-18808-Ljbffr

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE This role is part of the R&D Microbiology team and involves leading the application and interpretation of standards and regulations related to PDI's microbiological and sterility assurance control programs. Key responsibilities include analyzing data, developing tactical plans, implementing procedures, and leading remediation projects. Additionally, you'll conduct scientific research to support PDI's growth strategies, ensuring that our products meet stringent microbiological and sterility standards. The position is a key component of scientific advancement in skin antiseptics and medical device sterilization. Primarily, the role supports new market launches with input across all facets of project progression including scientific insights, prototype assessment and registration testing to meet regulatory requirements. This position requires strong cross-functional collaboration and communication. In addition, developing equity building studies that enhance PDI's current portfolio to provide a competitive edge in a challenging marketplace. ESSENTIAL FUNCTIONS AND BASIC DUTIES RESEARCH & DEVELOPMENT: Act as a sterilization and microbiology subject matter expert (SME), by supporting new product development, changes to existing commercial products. Guide product development teams with scheduling, budget estimates, deliverables, as needed to ensure project and product launch success, and compliance with applicable regulations, industry standards. Develop innovative microbiology solutions to support product development and meet regulatory requirements. Provide technical solutions to product development and engineering teams using various fields of science and sterilization theory and practice. Lead cycle development, validation, requalification activities, as well as product-specific sterilization qualifications and adoptions. LABORATORY SUPPORT: Analyze samples, ensure compliance, and prepare, sterilize, and evaluate products with precision. Optimize laboratory space to ensure an efficient flow of work. Develop and refine methods, utilizing various techniques and instrumentation for accurate results Create new SOPs where gaps exist. Maintain SOP version revisions for continuous improvement initiatives. Maintain detailed records and partner with teams to ensure compliance and efficiency. CROSS-FUNCTIONAL SUPPORT: Lead formulators to determine the correct method and dosage for sterile products Work with packaging and operations to ensure appropriate sterility assurance level Identify technical and project risks. Drive quick problem-solving, manage risks, and align teams on project goals. Prepare technical reports and technical presentations for internal meetings. Provide input to regulatory strategies as it relates to sterilization validation and verification PERFORMANCE MEASUREMENTS Ability to work in partnership with the product development and regulatory functions. Communicate scientific findings clearly and make meaningful contributions to projects. Support work stream timelines and be able to balance priorities according to stakeholder needs. Able to communicate and cooperate with other team members and cross function teams effectively. Demonstrate ability to add value to the organization through scientific excellence. Take ownership for assigned projects and self-lead initiatives. QUALIFICATIONS EDUCATION/CERTIFICATION University Degree in a Biological Science required Masters/Ph.D. an advantage REQUIRED KNOWLEDGE Previous experience in a regulated R&D environment supporting Sterile Products. Strong Microbiology understanding. Working knowledge of FDA regulations EXPERIENCE REQUIRED 5+ years' experience in sterilization or microbiology for regulated products Responsible for ensuring compliance with standards governing Ethylene Oxide, Dry Heat, X-Ray and Gamma sterilization Experience in working in GxP laboratory facilities. SKILLS/ABILITIES Excellent communication skills (verbal / written). Ability to explain science to management. Prudent risk taker. Identifies opportunities and takes risks to achieve objectives. Simplify complex ideas, collaborate effectively, deliver results, and innovate in sterility assurance. Able to work on multiple projects of varying complexity. Computer literate (Outlook / Word / Excel). SALARY RANGE $65,000 - $90,000 annually BENEFITS PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes: Medical, behavioral & prescription drug coverage Health Savings Account (HSA) Dental Vision 401(k) savings plan with company match and profit sharing Basic and supplemental Life and AD&D insurance Flexible Spending Accounts (FSAs) Short & long-term disability Employee Assistance Program (EAP) Health Advocacy Program PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts. At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.