Associate scientist jobs in Plainfield, NJ

The Associate Scientist MSAT Advanced Therapies Validation is responsible for validating supporting processes, implementing improvements within commercial manufacturing, and managing the lifecycle of these processes. The Associate Scientist acts as a Subject Matter Expert for validation studies, particularly in optimizing commercial manufacturing of lentiviral vectors, and liaises with various stakeholder departments. Responsibilities: Contribute to Life Cycle Management (LCM) and New Technology Introduction for the site. Execute validation of supporting processes (e.g.,mixing, sterilization, thermal processing, bio-decontamination). Support the introduction of new technologies and digitalization projects through validation protocol execution. Support the introduction of new materials via execution of validation protocols. Validate process parameters (e.g., process hold times). Contribute to Life Cycle Management projects. Act as Subject Matter Expert for one or more validation categories. Leverage the global MSAT network to identify and implement best practices. Author and review well-documented protocols and reports for all processes to be qualified/validated, in accordance with corporate/site guidelines, procedures, regulatory requirements, and industry best practices. Coordinate and support the execution of validation studies that conform to site standards and client guidelines, while meeting quality requirements. Support the site change control program by performing validation impact assessments and delivering the resulting implementation plan. Investigate deviations associated with process validation activities and oversee pre-validation and validation activities resulting from technical changes. Propose and formalize enhancements to qualification and validation processes and procedures to support process validation throughout the lifecycle and ensure program sustainability. Assist with writing Quality Risk Assessments for existing and new or changed processes. Ensure integration of global standards into local production processes. Support complex investigations and risk assessments. Act as SME during internal and external audits and inspections. Experience: Minimum of 2 years of relevant Manufacturing, Science, & Technology experience in the pharmaceutical industry. Experience with cell therapy manufacturing or viral vector manufacturing. GMP manufacturing and/or validation experience in pharmaceuticals. Skills in communication, planning, documentation, risk management, root cause problem-solving, and knowledge management. Understanding of regulatory requirements and industry guidelines for validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA, etc.). Affinity with process technology and digitalization in manufacturing. Capable of successful delivery of local small projects, regional project work streams, or departmental programs under supervision. Selects applicable engineering/scientific tactics. Works independently within scope, requiring general guidance. Skills: Stem Cell Therapy Good Manufacturing Practices (GMP) Drug Manufacturing Education: BSc in Biochemistry, Biotechnology, Chemical Engineering, or a related field. Advanced degree (MSc/PhD) in Biochemistry, Biotechnology, Chemical Engineering. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is 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, or status as a protected veteran. Recruiter Details: Name: Azhar Email: **************************** Internal Id: 25-53773

We are seeking an Analytical Scientist to join a reputable pharmaceutical manufacturing company to conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples. ** No Relocation, No C2C Candidates** Pay: Up to $50/hour. RESPONSIBILITIES: Conduct and document chemical analyses for raw materials, in-process goods, and finished products. Design, validate, and resolve issues with analytical methods, including HPLC for cleaning verification. Collect and analyze equipment cleaning validation samples. Prepare Certificates of Analysis, analytical reports, and maintain lab documentation. Peer-review records and support OOS or OOT investigations as per SOPs. Ensure compliance with SOPs, cGMPs, and regulatory requirements. Assist with environmental monitoring and other tasks as assigned. QUALIFICATIONS: 2 years hands-on method development experience (HPLC) Knowledge of cGMPs, pharmacopeia (USP, EP), and regulatory standards (21 CFR Part 210/211/820, ISO). Bachelor's in Chemistry-related discipline with 2+ years of analytical lab experience. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

The qualified candidate will take an active role in supporting drug development by applying a variety of analytical methodologies to support physical and chemical characterization of drug substances (including raw materials and intermediates) and drug products. Working knowledge of analytical (e.g., HPLC-UV, HPLC-MS, GC-MS, spectroscopy) and physical chemical techniques (e.g., particle size, dissolution) used for the characterization of pharmaceutical substances and products is desired. Hand-on experience in HPLC method development is highly desired. Position level varies from bench chemist to principle scientist, depending on experience. Principal Responsibilities: The individual will be responsible for performing laboratory work in support of analytical testing of pharmaceutical projects, and relevant experience with the following analytical methodologies: chromatography, dissolution, KF, particle size will be desirable. Job responsibilities may include analytical method development and validation; stability and release testing; testing to support pharmaceutical development efforts; direct interaction with project team members, including presentation of data; critical review of data; preparation of technical reports; and evaluation of new instrumentation or analytical techniques. The candidate must be able to interact effectively with peers and leaders as part of a multi-disciplinary team and work in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required. Qualifications The position requires a B.S, M.S. in Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, or Pharmaceutical Sciences with relevant working experience in pharmaceutical industry. Working knowledge in analytical method development and validation under cGMP environment. Experience with a wide-variety of software and information systems (e.g. Empower, ChemStation, or LIMS). Experience in problem-solving skills and instrument trouble-shooting. Good oral and written communication skills and the ability to write and review technical reports and scientific papers are desired. Working knowledge of pharmaceutical product development, CMC regulatory requirements, project management; and capability to collaborate with colleagues.

6 month contract w/ renewal 3 days onsite in Jersey City, NJ We are seeking a Clinical Scientist Data Reviewer that will support the scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate technical skills and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor and supporter in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results. This role will be focused on the detailed and critical safety data review efforts from study start-up through final CSR. The Clinical Scientist Data Reviewer is a crucial role in analyzing and interpreting clinical trial data to ensure accuracy, integrity, and compliance with regulatory requirements. There is additional room for growth and leadership opportunities in this role. Responsible for supporting specific aspects of clinical/scientific execution of clinical protocol(s). This may include: Serving as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team Supporting the clinical study team as part of the clinical sciences functional line which is closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance (as well as other functional areas in this matrix environment) Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on critical and key study deliverables Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming Collaborating cross-functionally to review clinical data to ensure quality, completeness, and integrity of trial conduct Potential to provide tactical/scientific mentorship to other clinical scientists and move into Clinical Scientist lead role as well as focus on scientific growth and development Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate) Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs Qualifications 6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor's degree in a relevant scientific discipline. Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred. Experience within oncology preferred Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH) Ability to manage multiple competing priorities with good planning, time management and prioritization skills Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports Interact with key stakeholders across Clinical Development functional areas Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals Influence opinions and decisions of internal and external customers / vendors, across functional areas Problem solving, prioritization, conflict resolution and critical thinking skills Strong communication, technical writing, and presentation skills experience

A recognized company in New Jersey is actively seeking a new Senior Scientist to join their growing Health Economics Resources initiatives. In this role, the Senior Scientist will be responsible for supporting the design, execution, and communication of observational studies using diverse RWD sources. Responsibilities: Support implementation of strategies to demonstrate the unmet need in disease with focus on outcomes meaningful to payers, clinical decision-makers, and regulators Assist with research to generate evidence necessary to demonstrate product differentiation and value for commercial/market access needs support clinical development, regulatory and safety needs (real-world evidence and epidemiology studies) Partner with CORE asset leads in development and execution of RWE studies delivered through hands-on analytics execution Evaluate new and emerging data modalities (e.g., claims, EHR, social determinants of health, genomics, biomarkers, clinical notes) and conduct feasibility assessments to match study objectives with optimal RWD sources (claims, EHR, registries, patient-generated data) Execute studies by managing table shells, analytic data file, analysis plan, programming, statistical methods, and quality control per regulatory and scientific standards Conduct quality assurance and code validation, review programming code and data Draft analysis reports and support the final publication/presentation of results Perform other duties, as needed Qualifications: 3+ years of experience in Real-World Evidence Generation and Epidemiology Analytics Graduate (PhD or Masters) degree in Epidemiology, Biostatistics, Public Health, or related field Working knowledge of the structure and caveats of Healthcare Claims Databases, Electronic Medical Records and/or Hospital Billing Data, Cancer Registry Data (SEER), Linked Dataset, etc. Knowledge in Epidemiologic and Statistical concepts, such as confounding, bias, cumulative incidence, incidence rate, regression models, survival analyses. Knowledge of Research Design and an ability to apply appropriate Statistical Methods common in outcomes research & epidemiology (survival analysis/modeling, regression analysis, IPTW, MAIC, causal inference, etc) Hands-on proficiency in Statistical Programming (SAS, R, Python) on Real-World Oncology Claims / EHR Data & AI/ML frameworks Solid problem solving and time management skills Great interpersonal skills Excellent communication skills (written and verbal) Strong attention to detail Highly organized Able to multitask efficiently and effectively Desired Skills: Oncology experience

The Chemical Biotechnologies Group at Merck is seeking an experienced researcher to support our high throughput capabilities. The mission of the group is to invent, develop, and implement biomolecules and biocatalytic process to advance Merck's pipeline and our impact on the scientific community. This position in our biochemistry team is responsible for lysing E. coli cell pellets to liberate enzyme in solution or generate enzyme from in vitro transcription (iv TT) mix, setting up reactions using this solution as a catalyst solution, quenching reactions and prep them for HPLC analysis, running the HPLC, and analyzing the data generated in support of our protein directed evolution workflow. The candidate will perform high throughput workflows with 96 or 384 well formats using various automation instruments. The candidate will have hand-on, extensive experience with instrumentation essential for monitoring substrates and products profiles for reactions, especially Agilent UPLC systems. In this position, the candidate will have the opportunity to work with a diverse group of team members to effectively coordinate efforts and operate multiple projects. The candidate ensures activities of assignments are executed such that project deliverables and timelines are met.

cinq à sept sank·ah·set sæŋk'e'set n : The time between late afternoon and early evening when streets are awash in the warm glow of the vanishing sun and anything is possible Sharing its name with the French term for the liminal moment linking late afternoon and early evening, Cinq à Sept brings the intriguing tension between day and night to a new advanced contemporary collection. Inspired by the hours between 5 and 7 p.m., when city streets are awash in the warm glow of the vanishing sun and office desks are abandoned for cocktails and as-yet unknown possibilities, Cinq à Sept embodies a deliberate balance between sophistication and ease, youthful daring and confident allure. The collection's modern feminine aesthetic embraces unexpected details and striking silhouettes, resulting in clothing that draw their romance and sexiness from the woman wearing them. ROLE OVERVIEW We are seeking a highly motivated and detail-oriented Fabric Research & Development Associate to join our team and support material development from initial concept through to pre-production. This role plays a key part in bringing seasonal fashion collections to life by ensuring the right materials are developed, sourced, and delivered on time. The ideal candidate is collaborative, organized, and an excellent communicator, with a strong understanding of textiles and a passion for fashion. You'll work closely with mills, suppliers, and internal design, production, and merchandising teams to manage seasonal development of fabrics, leathers, and trims. Responsibilities include tracking development timelines, reviewing quality and cost, maintaining technical documentation, coordinating sample and bulk orders, and ensuring timely delivery. You will also maintain an organized and up-to-date fabric library that supports the creative process. KEY RESPONSIBILITIES: Support seasonal fabric, leather and trim development by coordinating with suppliers and gathering key details such as pricing, minimums, and technical specs Review new materials for quality, performance, and bulk feasibility; flag potential issues to the Fabric Manager Communicate daily with mills to track development progress, troubleshoot delays, and ensure timelines stay on track Manage Purchase Orders - send all POs for Test, Proto and Sample goods; partner with Accounts Payable team to close out all invoices as needed Help manage sampling budgets and assist with tracking development costs Request FDS sheets and work with suppliers on prices, minimums, fabric width, and fabric content Collect and review technical documentation for all materials; identify and escalate any gaps or concerns Collaborate with Design, Product Development and Production on fabric direction and needs for early buys and special programs Keep precise, detailed records to track seasonal material decisions and fabric developments and ensure alignment with the development calendar from initial adoption through pre-production. PLM Management - enter and maintain all fabric information and attributes ensuring ongoing accuracy Participate in vendor meetings and industry shows to stay informed on trends and innovations Maintain organized fabric, leather, and trim libraries, including liability materials Keep precise and detailed records of all fabric developments from initial adoption through to pre- production Preparation and sending of sample yardage and bulk cutting to production Support last-minute material sourcing during key development phases and styling weeks YOUR PROFILE: Degree in Textiles or Apparel 3-5 years experience in Fabric or Product Development Must be able to multitask and manage multiple priorities and deadlines Experience working in PLM or similar systems proficient in Outlook, Excel and Adobe Programs Excellent communication skills both written and verbally Ability to stay organized in a fast-paced environment Self-motivated with the ability to work independently Extremely organized, detail oriented and proactive Strong time management skill with the ability to adapt to changing priorities and meet deadlines Understanding of the brands aesthetic

You will lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). You will lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. You will also work with other functional disciples to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine). POSITION RESPONSIBILITIES Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s) Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results Support execution for all FIH programs through proof-of concept Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics. Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors Support and assist in the development of publications, abstracts, and presentations May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials. Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of early signs of efficacy [ESoE] and POC trials). Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas. Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader Worldwide Research and Development (WRD) organization. Develop effective collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations. Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification. Establish and support relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and guidelines into development plans and study designs, as well as manage study recruitment, analysis, interpretation, and presentation of results. Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas, including key clinical development issues. Perform other duties as assigned related to clinical programs. Support functional area priorities and contribute to or lead departmental initiatives as requested. MINIMUM QUALIFICATIONS / KEY SKILLS Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies Experience in or strong understanding of Oncology Drug Development especially in Early Development Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. Strong scientific writing skills and communication skills (written and verbal) Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis. Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations. Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance. Experience building consensus and driving change across all levels of the organization including senior management. Data listing review experience Critical thinker, with experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform PREFERRED QUALIFICATION Experience leading a team This position does not require you to be medical qualified. Demonstrates diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Perform complex data analysis NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 5-10% Travel Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Perform complex data analysis NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Work Location Assignment: Hybrid The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical

Analytical Chemist will be engaged in the different laboratory testing using a range of analytical equipment and techniques within GMP laboratory. MAJOR DUTIES/RESPONSIBILITIES: Perform assigned testing including but not limited to the physical, chemical tests per in-house written procedures and compendial monograph for the raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemistry, physical and instrumental techniques such as LC, GC, UV-Vis Spectrophotometer, dissolution, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments. Document work clearly and perform tests accurately. Record data and results as specified in documentation procedures. Maintain proper laboratory logbooks, notebooks and other records all the time. Report and participate in the deviations and investigations. Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity. · Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures (SOPs). · Perform laboratory related other duties as assigned. MINIMUM/PREFERRED REQUIREMENTS: Education: Bachelor's Degree in Science/Chemistry Experience: Based on the position level, must require minimum 2-10 years prior experience working in the Quality Control Laboratory in a cGMP environment, preferably in pharmaceutical industry. Hands on Empower-3 experience is plus. QC experience in Generic Pharmaceutical industries would be preferable Knowledge in Good Documentation practices. Knowledge in USP/ FDA BENEFITS: Offers a comprehensive benefits package to employees

Kenvue is currently recruiting for a: Product Development Scientist What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA , AVEENO , TYLENOL , LISTERINE , JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here. Role reports to: DIRECTOR 1 Location: North America, United States, New Jersey, Summit Work Location: Fully Onsite What you will do The Product Development Scientist will be responsible for formulating new baby products in line with brand strategies, conducting Design of Experiments and stability analyses, and providing technical support throughout the product lifecycle. Key duties include identifying and addressing project challenges, analyzing market trends for product differentiation, defining process parameters in collaboration with manufacturing, and participating in cross-functional teams for product execution. The role also involves planning and prioritizing multiple projects, maintaining organized documentation, drafting technical reports, and ensuring compliance with quality and regulatory standards. Key Responsibilities: · Formulate new products that align with the Baby brand strategy and pipeline with supervisor oversight. · Conduct Design of Experiments, laboratory activities and analysis with hands-on involvement. · Provide technical support for product lifecycle management, including post-commercialization support and troubleshooting technical issues. · Proactively identify project obstacles and technical risks, evaluating potential solutions to minimize impact through data-driven decision-making. · Analyze and translate key trends into insights, understanding the competitive landscape to enhance product uniqueness and differentiation. · Define critical process parameters and collaborate with manufacturing sites to establish process controls. · Participate in cross-functional regional and/or global project teams to execute new products. · Plan and prioritize multiple projects and tasks to meet deliverables, monitor ongoing activities and updating stakeholders. · Maintain accurate and organized records of project documents, data, and materials. · Manage routine organizational processes and complexity. · Draft and complete technical documents, including peer-reviewed manuscripts, development summary reports, specifications, and patent filings. · Adhere to established standards and processes (e.g., GDP, GLP) to ensure compliance with quality, safety, and regulatory requirements. Qualifications: What we are looking for Required: · Bachelor's degree in Science, Engineering, Pharmacy with pharmaceutical or consumer (cosmetics, OTC) experience · Minimum of 3 years of related experience or a Master's degree with 1-2 years of related experience · Ability to work cross-functionally in a team environment while being an individual contributor · Ability to handle routine processes and complexity, risk taking and decision making · Detail-oriented, organized, and able to manage multiple tasks · Technical writing skills that facilitate the creation of documents that are complete & accurate · Proficient oral and written communication skills · Effective presentations skills that are used to communicate clearly & informatively · MS Office (Word, Excel, PowerPoint) proficiency Desired: · Degree in Chemistry, Chemical Engineering, Industrial Pharmacy · Experience with consumer products, such as skin care, emulsions, cleansers, hair care, oral care, baby care and/or deodorant products · Good technical foundation of formulated products including emulsions, surfactants, suspensions, structured liquids and an understanding of material chemistry · Experience collaborating with external partners (manufacturing vendors), suppliers, and technical project management · Familiarity with cGMP and other regulatory requirements What's in it for you Annual base salary for new hires in this position ranges: $81,175.00 - $114,600.00 This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors. Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time & More! Learning & Development Opportunities Kenvuer Impact Networks This list could vary based on location/region *Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents. Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements. Essential Duties & Responsibilities Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis. Provides technical direction in the execution and development of the purification process. Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment. Ensure that engineering and clinical batches are executed in a timely manner. Establishes operating equipment specifications and improves manufacturing techniques. Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment. Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies. Coordinate the conduction of investigations and corrections for issues found during the batch execution process. Performs other functions as required or assigned Complies with all company policies and standards Requirements Education: Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 4- 5 years of related experience in the biopharmaceutical industry. Previous experience working in GMP and aseptic manufacturing environment. Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds. Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation. Special Skills: Ability to work with other team members and independently - good interpersonal skills. Good communication skills: verbal and written, good computer and organization skills, detail oriented. Basic computer skills, including knowledge of Word, Excel and spread sheet Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review. Knowledgeable in cleaning verification/validation. Work Environment & Physical Demands: General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved. Supervisory Responsibility, if any: No This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Scientist II, Drug Product Development WuXi Biologics Cranbury, New Jersey, United States (On-site) Job Title - Scientist ll, Drug Product Development and Manufacturing WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies. Job Summary Drug product development and manufacturing (DP) is seeking a scientist to join our department. The successful candidate will be expected to work as part of a team that focuses on the activities including but not limited to formulation development, drug product manufacturing process development and technical transfer, clinical in use compatibility study, and clinical drug product manufacturing. Work closely with analytical sciences (AS) and process development and drug product manufacturing teams to lead drug product process development and manufacturing projects. Responsible for study design, execution and troubleshooting to meet client project deliverables. Author technical documents including SOPs, protocols, study reports, etc. Responsibilities * Adhere to WuXi Biologics' quality system and work under cGMP to manufacturing clinical drug products. * Execute drug product manufacturing processes development and tech transfer. * Execute liquid formulation development and fill/finish process scaled down model. * Develop injectable drug product manufacturing process including container closure selection, drug product compatibility with manufacturing process, and provide tech transfer and manufacturing support including deviation investigation and trouble shooting. * Author technical documents including SOPs, protocols, study reports, and support regulatory filing. * Support protein analyses and biophysical characterization of protein drug products in conjunction with analytical science team and process development team. * Apply scientific knowledge and experience to assigned projects. Interface extensively in a matrixed environment with process development, analytical development and manufacturing teams for process investigation support, assess new formulation/DPD technologies, support on-going and upcoming client projects. * Communicate effectively on the findings of research and development internally and externally to ensure alignment among WuXi Biologics and with clients. Preferred: * Drug product process development experience with large molecules for parenteral administration * Development and characterization of aseptic fill and finish operations including freeze/thaw, compounding, mixing, sterile filtration, filling, stoppering, visual inspection, * Manufacturing experience of biologics drug product in clinical settings. * Experience in biophysical characterization of the biologics drug products. Qualifications: * PhD with 0-2 years of experience in Pharmaceutics, Pharmaceutical Sciences, Pharmaceutical Chemistry or Chemistry Candidate must possess knowledge in formulation, and drug product process development areas. Understand current industry practice and scientific reasoning for biologics drug product process development. * Be qualified to work in cGMP environment. With hands-on experience with Vanrx Robotic filling system. * Strong communications skills. Great team player and ability to build positive collaboration with internal stakeholders, vendors and clients to achieve alignment and work effectively. * Must work in a self-motivated, multiple tasks, highly flexible, well-organized and detailed-oriented style. * May require some evening work hours and conference call time to meet global team time zones. * The does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position are required to perform other job-related duties/responsibilities based on their expertise and company business needs. The Anticipated salary for this position is $70,000-110,000 The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs. 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, or protected veteran status and will not be discriminated against on the basis of disability

Chronosphere Chronosphere is the observability platform built for control in the modern, containerized world. Chronosphere empowers customers to focus on the data and insights that matter by reducing data complexity, optimizing costs, and remediating issues faster. The observability platform reduces data volumes and associated costs by 60% on average while saving developers thousands of hours. Chronosphere's Fluent Bit-based Telemetry Pipeline optimizes and simplifies observability and security log data. The product transforms logs at the source and routes them to any destination without lock-in. Recognized as a leader by major analyst firms, Chronosphere is trusted by the world's most innovative brands, including Snap, Robinhood, DoorDash, and Zillow. Learn more at Chronosphere.io. Follow at LinkedIn and X. About the role Responsible for owning the vision, strategy and execution plan to bring new innovative products to market, starting with Chronosphere's log data management product. Responsible for bridging Chronosphere's customers and the Engineering team, building feedback loops and testing hypotheses to develop a deeply technical product that will serve a deeply technical Audience. You Will Own the vision, strategy roadmap and execution of new SaaS software products, specifically data driven products starting with Chronosphere's log data management product; Perform primary research and interview end-users and buyers to design these software products; Uncover innovative approaches to solve end-user needs through the use of Artificial Intelligence (AI), Machine Learning (ML) and/or data science techniques; Bring the new products to market from inception to significant revenue; Develop a deep understanding of Chronosphere's competition and their businesses; Set priorities and shape the roadmap for building and developing the new product; Communicate priorities and the roadmap, and align the team around them; Convert product concepts for the new product into projects buildable by software engineering teams; Serve as a product owner for a Scrum team working on observability features for the new log management product; Manage the backlog, groom stories, and breakdown tasks for the design, development, and building of the new product in an Agile framework; Develop a feedback system with a select group of customers to get feedback on new products to drive iterative product improvements; Drive new product requirements down onto our Data stores and SaaS infrastructure teams; Coordinate with product marketing and sales teams on positioning and messaging for the new product; Hire and manage a team of product managers; and Own the revenue target and incubate the business. You have Bachelor's degree or foreign equivalent in Computer Science, Computer Engineering, Management Science, or a related field followed by 7 years of post-baccalaureate experience as a Product Manager. Experience must include the following, which may have been gained concurrently: 5 years of experience managing SaaS (software as a service) products on cloud technologies such as Amazon Web Services (AWS), Google Cloud Platform (GCP) or Microsoft Azure; 5 Years of experience in a SCRUM or Agile software development processes; 5 years of experience overseeing entire product lifecycle including product vision, strategy, and design; 3 years of experience using, running, developing and building solutions on modern data storage technologies such as Data Platforms or No-SQL databases; 3 years of experience using, running, developing and building solutions on traditional Relational Database Management Systems (RDMBS) and using Structured Query Language (SQL); 3 years of experience developing applications using object-oriented languages including C#; 3 years of experience building end-user solutions leveraging Artificial Intelligence models, Machine Learning models, and data science techniques; 3 years of experience managing a team of 2 or more product managers. May telecommute from anywhere in the U.S. 15% Travel required across the United States. Location 33 Irving Place, Suite 8109, New York, NY 10004. Salary: $256,000 to $300,000 per year. Full-time employment. Please apply online at ********************************* This position is part of Chronosphere Inc.'s employee referral program and is eligible for an employee referral incentive. #LI-DNI Our benefits Health Insurance Coverage Flexible Time Off Competitive Salary Stock Options And More Chronosphere is an equal opportunity employer. You're encouraged to apply even if your experience doesn't line up exactly with the job description. Your skills, passion, and desire to make a difference will stand out. At Chronosphere, we welcome diverse perspectives and people who think rigorously and aren't afraid to challenge the standard. If you need additional accommodations to feel comfortable during your interview process, please email us at ********************** Before clicking “Submit Application”. To support our Diversity, Equity, and Inclusion (DEI) initiatives, we urge applicants to omit personal identifiers, including names, and any details that explicitly indicate gender or ethnicity from their applications to reduce bias. However, applying through our Applicant Tracking System (ATS) will include identifiable contact information. Although this step is optional, Chronosphere is deeply committed to DEI. We recognize that achieving DEI is an ongoing journey for us as a company, and we believe it begins with our approach to hiring. Identifying information includes your name, photos, LinkedIn URL, email address, and more.

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Associate Research Scientist Formulation Development Position Overview: As a Formulation Development Scientist, you will play a crucial role in executing formulation development activities under supervision. You will perform hands-on experiments in the laboratory, including prototyping, material characterization, accelerated stability studies, and initial process design. You will draft formulation development reports and help execute the formulation development strategy for assigned projects. Your role involves solving technical problems by applying scientific knowledge and creative thinking to create simple, cost-effective, and compliant solutions. You will test potential formulations, support laboratory activities, and participate in innovation activities by making prototypes for proposed ideas and concepts. You will contribute to innovation by leading ideations based on category innovation strategy or consumer insights, attending product research to understand consumer feedback, and actively searching for external new drug delivery technologies for new products. You will be instrumental in developing and testing the composition and physical attributes of new products for a stable and process-robust formulation. YOUR TASKS AND RESPONSIBILITIES: * Perform hands-on execution of experiments in the laboratory such as prototyping, material characterization, accelerated stability studies, quality by design - design of experiments execution, initial process design, and drafting formulation development reports; * Help execute formulation development strategy for assigned projects; * Solve technical problems by applying scientific knowledge and creative thinking, creating simple, cost-effective, and compliant solutions; * Clearly identify and escalate formulation issues to supervisor and project team; * Test potential formulations by working with cross-functional project teams to determine experimental and stability test requirements, and reviewing data and conclusions for product testing and stability; * Support laboratory activities as formulation equipment "owner" and subject matter expert, including raw material ordering and naming, and ensuring equipment is in working order; * Participate in innovation activities by making prototypes for proposed ideas and concepts, proactively suggesting new product ideas based on consumer needs or innovation strategy, and actively looking for external technologies and capabilities to apply for internal prototypes; * Contribute to innovation by leading ideations based on category innovation strategy or consumer insights, attending product research to understand consumer feedback on new products, making prototypes against new product ideas, presenting new product ideas and prototypes to category teams, and actively searching for external new drug delivery technologies for new products; * Develop and test the composition and physical attributes of new products for a stable and process-robust formulation; * Contribute to innovation and identify technologies for new product ideas. WHO YOU ARE: Bayer seeks an incumbent who possesses the following: Required Qualifications: * Bachelor's degree; * Ability to work hands-on in a laboratory setting; * Must be passionate about innovation, research, and continuous learning; * Ability to be a fast learner; * Ability to work with cross-functional teams in a rapidly changing environment; * Strong oral and written communication skills; * Experience with design of experiments (DOE) and data analysis; * Ability to work accurately and efficiently on multiple projects under aggressive timelines; * Strong computer and digital skills - Microsoft Office, DOE Software, modeling, and simulation. Preferred Qualifications: * Bachelor's degree in Pharmacy, Chemical Engineering, or Science with 2 years of experience in product development or testing; * Master's degree in Pharmaceutical Sciences, Industrial Pharmacy, Chemical Engineering, or Science with 0-1 years of experience in product development or testing. Employees can expect to be paid a salary between $60,000.00 - $90,000.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least December 22, 2025. #LI-US YOUR APPLICATION Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer is an E-Verify Employer. Location:United States : New Jersey : Morristown Division:Consumer Health Reference Code:858290 Contact Us Email:hrop_*************

Reproductive Medicine Associates of New York, one of the top fertility centers in the country, is seeking an experienced Senior Embryologist to work in our brand-new state of the art clinical laboratory in our New York City location. Responsibilities Include: Quality control procedures Laboratory set-up Media and culture dish preparation Sperm preparation Conventional insemination Oocyte retrieval Fertilization assessment Embryo cryopreservation and thaw Biopsies ICSI What Is Needed: Ph.D., MS or BS in a chemical, physical, biological, or clinical laboratory science with 2-3 years of specific clinical laboratory experience required Must have the ability to perform concentrated and complex mental activity with frequent involvement in complex and highly technical situations Must have the ability to make sound, independent judgments based on laboratory protocols, and be able to collaborate with other multidisciplinary team members in an appropriate fashion Must have the aptitude to learn to make appropriate judgments about the clinical significance of laboratory data Have skills to access, input, and retrieve information from a computer Must be able to communicate accurately and concisely Excellent attention to detail and interpersonal skills are required RMA of New York offers a great team-oriented working environment as well as a competitive salary and health benefits. Please visit our website: ************* Job Type: Full-time Pay: $120,000.00 - $170,000 per year Schedule: 4 day work week; at least one weekend day 10 hour shift Day shift Work Location: In person with potential to float to RMANY - Brooklyn as needed Ability to Relocate: New York, NY 10022: Relocate before starting work (Required) Benefits: Paid time off Health insurance Dental insurance Vision insurance 401(k) Employee assistance program Life insurance

Job Description IVI RMA of North America state-of-the-art fertility clinics is currently seeking a Mid-Level EMBRYOLOGIST to join our growing team at RMA Basking Ridge. This position will be responsible for executing IVF laboratory procedures according to established policies as well as adhering to RMA's quality assurance/control operating procedures. The ideal candidate will build on previous embryology experience and train to perform all aspects of clinical embryology independently and in accordance with RMA's Laboratory Philosophy, Mission, and Performance Standards. Responsibilities: Follow established policies for IVF procedures, specimen handling, and tissue storage Maintain quality assurance, quality control, and operating guidelines for lab services Adhere to quality control policies and documentation requirements. Follow OSHA requirements for safe lab operation Obtain proficiency to perform all lab services efficiently and reliably on an independent basis Participate in clinical and research lab operations as directed Identify problems that may adversely affect patients and facilitate a solution Participate in lab proficiency testing Attend laboratory meetings as requested Attend continuing education programs as requested Requirements: Bachelor's of Science 2+ years embryology experience Demonstrate an aptitude for performance of laboratory services Aptitude to make appropriate judgments regarding clinical significance of laboratory data Excellent work ethic and motivation to learn lab procedures High level of listening and counseling skills Aptitude to work independently and demonstrate good judgment Ability to access, input, and retrieve information from a computer. Knowledge of office procedure and office machines (i.e., computer, fax, copier, etc.) Must be able to work weekends and some holidays IVI-RMA offers a comprehensive benefits package to all employees who work a minimum of 30 hours per week. Medical, Dental, Vision Insurance Options Retirement 401K Plan Paid Time Off & Paid Holidays Company Paid: Life Insurance & Long-Term Disability & AD&D Flexible Spending Accounts Employee Assistance Program Tuition Reimbursement About IVIRMA Global: IVIRMA is the largest group in the world devoted exclusively to human Assisted Reproduction Technology. Along with the great privilege of providing fertility care to our patients, IVIRMA embraces the great responsibility of advancing the field of human reproduction. IVIRMA Innovation, as one of the pillars of IVIRMA Global, is a renowned leader in fertility research and science. Check out our websites at: *********************** & *********************** EEO “IVIRMA is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: IVIRMA is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at IVIRMA are based on business needs, job requirements and individual qualifications, without regard to race, color, religion and/or belief, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. IVIRMA will not tolerate discrimination or harassment based on any of these characteristics. IVIRMA encourages applicants of all ages.” 3 days a week Monday-Friday and every other weekend

A Product Development Scientist role involves a wide range of activities, including developing and optimizing new product formulations and processes, conducting laboratory testing and evaluations. Key responsibilities include batching several iterations, ensuring technical accuracy in product development through stability studies, and documentation. Working with the team, time management, attention to detail, strong analytical skills, strong communication, following the timeline. Consumer Products - Skin Health BA Degree 2 to 4 years' experience Will need to go between Summit and Skillman office, 830-5 Skills required: documentation work organizing samples, delivering samples batching exp 2 years of formulation exp Skillman for batching - 5 days a week - majority of the role is in Skillman paperwork done in summit (1 day in summit) 4 days Skillman and 1 day summit (depend on the workload and paperwork) Timings : 8:30-5- Flexible basic lab instruments intern exp will also work making 2 batches a day and 8 batches a week About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is 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, or status as a protected veteran. Recruiter Details: Name: I.Prudvi kumar Email: ******************************* Internal Id: 25-50776

You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within our Late-Stage Oncology portfolio. **Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. Responsible for scientific oversight, data integrity and quality of the clinical trial(s). Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate. Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders. In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s). Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, **OR** MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO **OR** BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO Clinical Research experience in the phase 2 - 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance Experience working on large data sets Proficiency with Microsoft Office and relevant scientific software Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations Experience building partnerships across the company to achieve the needs of the program **Demonstrates passion for helping patients with cancer and for the science of oncology Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. Work Location Assignment:** This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.Pfizer compensation structures and benefit packages are aligned based on the location of hire. Relocation assistance may be available based on business needs and/or eligibility. **Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Medical

Looking for candidates at Chemist I, II and III levels responsible for carrying out analytical method validation/verification activities and testing for Oral Solids, Oral Liquids, Topicals and Powders. MAJOR DUTIES/RESPONSIBILITIES: Develop/Validate/Verify analytical (HPLC, GC, ICP-MS/OES, other) methods for assay and impurities determination in drug substances and drug products. Perform wet chemistry and chromatographic testing for raw materials and products under development phase Perform stability studies for drug products in development phase and generate reports Develop and validate cleaning methods and generated study protocols and reports Prepare relevant protocols, reports, and final methods Maintain proper instrument calibration status Ensure that work is carried out safely and in compliance with the organization's quality system Ensure that quality documentation is generated and updated to reflect current best practice in a timely manner. Perform peer review at Chemist III level, not required if you're applying for Chemist I/II levels. Perform other duties as assigned. MINIMUM/PREFERRED REQUIREMENTS: Education: Bachelor or Master's degree in science or Pharmaceutics. Experience: Bachelor's with 2-7 years of experience in a generic pharmaceutical analytical lab. Master's is preferred. Candidates shall be considered for different positions based on educational qualification and experience. Good understanding of cGMPs is a must for experienced candidates. PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS: Laboratory and office environment Able to lift about 25 pounds. Able to stand and or sit for longer period of time. On-site, Full-time, Day Shift