Senior Scientist jobs at Takeda Pharmaceuticals U.S.A., Inc. - 1109 jobs

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

Principal Scientist, Innovation Management, Fremont CADescription As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Scientist, Innovation Management will act as a primary expert for upstream/drug substance development and manufacturing with a unique blend of expertise in biopharmaceutical upstream processes, digitalization, and data science. This role will identify and evaluate emerging technologies and companies that can enhance biopharmaceutical manufacturing. The incumbent will provide scientific and technical leadership to the team on both internal and external projects. Duties & Responsibilities Ensures direct report (intern & co-ops) safety, training, and supervision. Responsible for effective management of a team of technical experts. This is an individual contributor Role. Upstream/Drug Substance Development and Manufacturing: Leads the development and optimization of upstream processes for biopharmaceutical production. Oversees cell culture operations, including media development, bioreactor design, and scale-up processes. Ensures compliance with regulatory standards and quality control measures. Collaborates with cross-functional teams to integrate upstream processes with downstream and analytical development. Digitalization and Data Science: Implements digital tools and data analytics to enhance process understanding and control. Develops and applies predictive models for process optimization and troubleshooting. Utilizes machine learning and AI to drive continuous improvement in manufacturing processes. Manages data integrity and ensures robust data management practices. Scouting Technologies and Companies: Identifies and evaluates emerging technologies and companies that can enhance biopharmaceutical manufacturing. Conducts due diligence and feasibility assessments for potential technology acquisitions or partnerships. Collaborates with global teams to integrate new technologies into existing processes. Stays abreast of industry trends and advancements to maintain a competitive edge. Leadership and Team Collaboration: Provides scientific and technical leadership to the upstream development team. Mentors and develops team members, fostering a collaborative and high-performance culture. Manages project timelines, budgets, and resources effectively. Represents the company at industry conferences and scientific meetings. Requirements BS with ten-plus (10+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR MS with six-plus (6+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. OR PhD with three-plus (3+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field. Thorough knowledge of biotechnology process development methodologies such as cell culture, aseptic techniques, bioreactor operation and development, column chromatography, filtration, and UFDF. Knowledge of GMP biopharmaceutical manufacturing, including process validation and commercial manufacturing support. Four-plus (4+) years' experience in late-stage process development preferred. Two-plus (2+) years' experience leading in a matrixed environment preferred. Two-plus (2+) years' experience in data science, Machine learning, and statistical analysis skills Excellent verbal and written communication skills. Good documentation and presentation skills. Proven skills building and maintaining productive relationships with organizational partners such as Manufacturing and Quality. Ability to troubleshoot and challenge status quo processes and influence in a team environment. Ability to communicate complex results (e.g. hybrid models) to both internal and external stakeholders. Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Compensation Data This position offers a base salary typically between ($115,000) and ($181,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information. #J-18808-Ljbffr

A global biopharmaceutical company is looking for a Principal Scientist in Innovation Management. The role involves the development of upstream processes, oversight of biopharmaceutical production, and integration of digital tools in manufacturing. Candidates must have significant experience in biopharmaceutical manufacturing and possess strong leadership capabilities. This exciting opportunity advocates for collaboration, innovation, and a commitment to high-quality standards in a dynamic working environment. #J-18808-Ljbffr

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

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

A global healthcare company is hiring a Senior Medical Science Liaison for Solid Tumor Oncology in the Northeast. This role involves developing territory plans, engaging with KOLs, and addressing educational needs in the field. Candidates should have a doctorate and 2+ years of MSL experience, with a preference for oncology expertise. The position offers a competitive salary range, annual performance bonus, and a comprehensive benefits package including health insurance and retirement plans. #J-18808-Ljbffr

HTI is seeking a Metallurgical R&D Scientist for a brand-new facility in Augusta, GA. This is a great opportunity to work with a state-of-the-art facility and be an important contributor to the growing North American metals supply chain. What They Offer Full Medical, Dental, and Vision Benefits on Day 1 401(k) Match EAP, LTD, STD, and Life Insurance Competitive Vacation Package 12 Paid Holidays Relocation Assistance Available What You Need Bachelor's Degree in Chemical Engineering, Materials Science, Metallurgy, or a related field Minimum of 2 years of experience, ideally in R&D, materials analysis, or process engineering Recent graduates with relevant project or lab experience may be considered Strong understanding of non-ferrous metallurgy and metal extraction principles, especially copper metallurgy. Knowledge of pyrometallurgical, hydrometallurgical, and/or electrometallurgical processes Experience with: Material characterization and analysis Process troubleshooting and optimization Failure analysis and root cause investigation Familiarity with process simulation or thermodynamic modeling tools (FactSage, Thermo-Calc, HSC, etc.) is preferred but not required Experience preparing or interpreting process flow diagrams, phase diagrams, and thermodynamic calculations **Candidates must be eligible to work in the U.S. without sponsorship now AND in the FUTURE** What Your Role Will Look Like As the Metallurgical Research & Development Scientist, you will be integral to the development and enhancement of metallurgical processes, particularly in non-ferrous extractive metallurgy with a focus on copper. Collaborating with various departments, you will lead process improvement initiatives through simulation and modeling, contribute to R&D projects, and support the broader organization in achieving its production and efficiency goals. Key Responsibilities Collaborate closely with cross-functional teams, including Production, Supply Chain, and Maintenance, to develop and optimize metallurgical processes. Design and improve processes through simulation, focusing on enhancing production efficiency and effectiveness. Conduct research and development projects, such as developing new copper alloys and analyzing the impact of using different types of electronic waste. Utilize process simulation software to model and simulate metallurgical processes, implementing improvements to existing operations. Prepare detailed process flow diagrams and perform calculations related to mass balance, heat balance, and phase diagrams. Support other departments by providing expertise on chemical and material compositions and addressing process-related questions. Ensure compliance with environmental, health, and safety standards, contributing to the development of operating instructions and risk assessments. Participate in the ongoing development of R&D labs on-site, with a focus on future process improvements and innovations.

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

Senior Analytical Scientist (R&D/Product Development) position with a large, well-established pharmaceutical manufacturing company in Greenville, SC. This is a direct hire, full time, onsite role. Relocation assistance is available for candidates located outside of the greater Greenville, SC area. Salary is dependent upon education and experience. This company offers fantastic benefits, and a positive, team-oriented work environment. Requirements: Bachelor's degree in Chemistry 6+ years of experience as an Analytical Chemist or Scientist working in pharmaceutical product development/R&D with responsibility for the job duties listed below Must have experience developing and completing validation/verification of analytical methods to support product release and stability testing, and submitting products to the FDA Strong knowledge of cGMP and FDA regulations; USP and ICH are a plus HPLC, UPLC, GC, TLC, dissolution, particle size analysis, UV/Vis, FTIR, spectroscopy, titrations experience Chromatography software experience (Empower, OpenLab, etc.) Strong MS Office and document management skills (Word, Excel, Adobe Acrobat for PDF editing) Must have professional verbal and written communication skills, with strong technical writing abilities for creating SOP's, reports and FDA submittals Ability and desire to mentor and train junior team members Must be authorized to work in the United States without visa sponsorship (both now and in the future) Additional experience that is a plus: Liquid oral solution/suspension experience ICP experience Mass spectrometry experience (MS, LC-MS, GC-MS, ICP-MS) Extractables/leachables identification for N-nitrosamines Previous experience in a Senior Scientist role Master's degree in Chemistry Job Summary: Responsible for developing, validating, and verifying complex analytical methods to support drug product release and stability testing. This role includes designing and executing method validation/verification protocols and reports, preparing technical documentation (SOP's, test methods, etc.) and independently managing projects all the way through to FDA submission. This team member will troubleshoot analytical challenges, provide technical solutions, and ensure compliance with FDA/ICH regulations. Job Duties: Develop and complete validation/verification of complex analytical methods to support product release and stability testing Design, prepare, and execute method validation/verification and transfer protocols, reports, analytical methods, and SOPs, etc. Independently manage assigned projects Perform laboratory investigations and prepare necessary reports as needed Support timely deficiency responses Evaluating, troubleshooting, and improving existing analytical methods when necessary Maintain consistency with organizational objectives while providing imaginative and practicable technical solutions to an array of difficult problems Provide and receive peer reviews Train and mentor junior scientists on analytical techniques This employee will spend approximately 50% of their work time in the lab and the other 50% developing and writing SOP's, technical documentation, FDA submittals, and reports Support other duties as assigned

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

PRECISION AQ, the top payer marketing agency, supports global pharmaceutical and life sciences clients in the achievement of commercial excellence. We excel at demonstrating the economic, clinical, and societal value of creative medical treatments to payers, providers, patients, and policymakers. As leaders in the generation, analysis, and communication of that evidence, we are improving market access and supporting our clients in their mission of improving care for patients around the world. As a Senior Scientific Associate, you will write medical content for our clients working with internal teams to ensure that the client vision is achieved impacting our clients who are developing groundbreaking medicines/treatments who are working to make medicines accessible and affordable. We provide external training, mentorship, and operate in a cross-functional project team environment. About You: You have a strong interest in managed markets and consider yourself a life-long learner You enjoy writing and researching You stay on top of trends in the medical/scientific community You love rolling up your sleeves and taking projects from start to finish You have an eye for detail and can accurately convey complex information in a simple way You are passionate about providing medical insights, supplying creative ideas, and developing high quality content that allows you to use scientific/medical knowledge and demonstrate your writing skills What you can expect day-to-day: Serving as medical point person on assigned accounts Developing, writing and translating complex scientific data to a broad audience across multiple and wide-ranging therapeutic areas Ensuring project quality and outcomes by demonstrating in depth technical expertise of assigned therapeutic category and/or managed care areas Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.) Working closely with account teams to refine content in keeping with strategic imperatives Communicating medical content with internal team and pharmaceutical clients, as necessary Attending medical, legal, regulatory review meetings Participating in internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings Chipping in ideas for new business proposals and tactical planning within assigned accounts Mentoring junior level writers Qualifications: Doctorate level degree such as PharmDs or PhDs 2-4 years in medical communications, healthcare agency, medical education, or similar field Ability to translate complex scientific concepts for a variety of managed care audiences Ability to prioritize projects, juggle competing client priorities & meet deadlines without sacrificing quality Flexibility to meet the demands of a dynamic environment Strong written and verbal social skills Ability to travel for occasion Other Candidates with a BA/BS plus a minimum of 3 years of experience in the medical communication, pharmaceutical and/or healthcare industry can be considered for Senior Medical Writer level #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$87,500-$122,500 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Applications are sought for an opportunity in the Vaccine and Advanced Biotechnologies (VAX) Process R&D department, which is part of the our Research & Development Division. The individual will support our Company's downstream process development efforts for Vaccine programs at West Point, PA. 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 our company's pipeline. Our vaccines downstream process development team develops safe, scalable, robust, cost-effective downstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all vaccine modalities. 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. The candidate will be responsible for scientific/technical leadership of a bioconjugation process development team, and will also be a critical member of cross-functional program/project teams. This role will require frequent collaboration with cross-functional teams including Analytical, Formulation, Process Chemistry, Enabling Technologies, and Manufacturing colleagues. The candidate should have a strong background in downstream bioprocess/bioconjugation design, including reaction steps, filtration (tangential and normal flow) and column chromatography. Preferably, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Primary responsibilities include, but are not limited to: Lead downstream process design and development for conjugate vaccine candidates. Design, execute, and analyze process development experiments to maximize conjugate vaccine production processes, thereby de-risking later stage development and tech transfer. Represent functional area in cross-functional and strategic teams engaged in vaccine development. Lead tech transfer of vaccine bioconjugation processes for clinical and commercial manufacture. Serve as scientific/technical mentor for junior staff, providing technical guidance in the various aspects of downstream bioprocess/bioconjugation development. Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development. Analysis of experiments through analytical techniques including HPLC, light scattering, and spectroscopy. Data interpretation and presentation, manuscript/patent preparation. Education Minimum Requirement: BS, MS or PhD in engineering or bio/chemical sciences: Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biochemistry, Molecular Biology, Biotechnology For BS candidates, at least eight (8) 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: Strong scientific and hands-on understanding of downstream bioprocess/bioconjugation unit operations, biotherapeutic and/or vaccine process development and sound understanding of scale-up principles. At least five (5) years of hands-on laboratory experience in downstream bioprocess/bioconjugation development. 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 with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates), conjugation chemistry and downstream bioconjugate processing. Experience in leading technical development teams and mentoring others. 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 their 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 themselves and their team. Position may require working with infectious agents, pathogens, and/or potent compounds with appropriate engineering controls and PPE. Some travel or off-hours work may be required. #PRD Required Skills: Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Bioconjugation, Biomedical Engineering, Biomedical Sciences, Biotechnology, Cell Line Development, Chemical Engineering, Chemical Technology, Column Chromatography, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunochemistry, Innovation, Interpersonal Relationships, Laboratory Safety, Leading Project Teams, Machine Learning (ML), Molecular Biology, Pharmaceutical Formulations {+ 4 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 $142,400.00 - $224,100.00 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: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 02/10/2026 *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.

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

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

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

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

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

Our Senior Formulation Scientist, Development is responsible for managing and supporting formulating new products and any new formulations for existing products for continuous process improvement. This role will collaborate with the development team to support the Pharmacy Services and Technical Services department in developing new and improving existing formulations that will be transferred into commercial products. The Senior Formulation Scientist, Development will also support the Technical Services team as a subject matter expert with addressing important manufacturing issues. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Senior Formulation Scientist, Development Does Each Day: * Innovate and develop new products/patents * Design and develop protocols for new product development and improvement of existing products * Supports administrative activities and meetings for formulation process strategies * Collaborates with Pharmacy Services in developing new product formulations * Collaborates with Technical Services in transferring new products to commercial products * Ensures product deadlines are met and projects are handled in a professional manner * Present ideas for modifying existing procedures and suggest alternative methods to improve results * Perform scientific literature searches and evaluations as required * Collaborating with development in producing for writing new drug formulations * Recommending scientifically sound drug formulations for new products and existing products * Review drug/diluent compatibilities * Ensures pharmaceutical formulations are correct for specific procedures and processes * Supports the Technical Support team with process validations and qualifications * Ensures all proper policies and procedures/work instructions are followed correctly within R&D development * Ensures that Master Formularies are up to date and makes any changes pursuant to process improvements and investigations * Ensures all duties and processes are in adherence with ISO standards, USP, and current good compounding practices * Perform change control processes and assist with managing timelines * Writing, maintaining, and improving standard operating procedures related to developed products * Practice and monitors good documentation practices Our Most Successful Senior Formulation Scientist, Development: * Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment) * Has good coordinating abilities, attention to detail with positive communication skills * Has excellent organizational skills with ability to manage multiple projects * Is proficient in Microsoft Office Minimum Requirements for this Role: * Ph.D. in analytical chemistry or equivalent or Master's degree with extensive experience * 7+ years' experience with formulation development in a pharmaceutical environment * 10 years advanced R&D at scientist/engineer level in pharmaceutical fields * Experience working with controlled substances & sterile injectables * Understanding of cGMP, FDA, ICH principles, guidance and regulation * Experience writing SOPs and critical regulated documents for internal and external business * 18+ years of age * Able to successfully complete a drug and background check * Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas Benefits of Working at Quva: * Set, full-time, consistent work schedule * Comprehensive health and wellness benefits including medical, dental and vision * 401k retirement program with company match * 17 paid days off plus 8 paid holidays per year * Occasional weekend and overtime opportunities with advance notice * National, industry-leading high growth company with future career advancement opportunities About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will." California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

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