Scientist jobs in Berkeley Heights, NJ - 1,727 jobs

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.

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

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 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

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

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 Analytical Development Position Overview: As a key member of our Analytical Development team, you will perform critical analytical laboratory work to support product development and ensure that analytical methods are both validated and QC friendly. Your role is essential in providing accurate and timely documentation of experiments and results, following written procedures and analytical laboratory practices to ensure work quality and compliance. You will also present your findings to colleagues within the Analytical Development functional community and cross-functional project teams. YOUR TASKS AND RESPONSIBILITIES: Perform analytical laboratory work to support product development; Conduct laboratory work to ensure analytical methods can be validated and are QC friendly; Provide accurate and timely documentation of experiments and results into notebooks and LIMS (if required); Follow written procedures and analytical laboratory practices to ensure work quality and compliance; Present findings to colleagues within the Analytical Development functional community and cross-functional project teams. WHO YOU ARE: Bayer seeks an incumbent who possesses the following: Required Qualifications: A bachelor's degree in science, or international equivalent, with 1 or more years of proven experience; A Master's degree or higher, in science, or international equivalent, with 0 or more years of proven experience; Self-motivated to learn and develop within the organization; Excellent oral and written communication skills, with an emphasis on clarity and conciseness. Preferred Qualifications: Hands-on experience in HPLC, UV-Vis, Dissolution, and other applicable analytical instrumentation; Knowledge of GMPs and LIMS. Employees can expect to be paid a salary between $99,253.06 - $148,879.60. 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 January 5, 2026. 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: 859549 Contact Us Email: hrop_*************

The Upstream Manufacturing Scientist is responsible for executing mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible for executing cell culture batches from 50 L to 1000 L volumes engineering and clinical batches in a cGMP environment. This position requires technical expertise in bioreactor operations, cell biology 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. Essential Duties & Responsibilities • Work with a collaborative team of manufacturing associates and engineers to execute upstream batches. • Perform cell culture and bioreactor operations at multiple scales. • Ensure that engineering and clinical batches are executed in a timely manner. • Establishes operating equipment specifications and improves manufacturing techniques. • Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment. • Ability to interpret and provide instructions furnished in written, oral, diagram, or schedule form. • Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies. • Review executed manufacturing and packaging batch records, executed and associated supporting documents. • 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 and Experience • Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 3+ years of related experience in the biopharmaceutical industry. • Expertise in independently conducting and directing the design, execution, analysis, and documentation of all states of process development. • Strong fundamental knowledge and subject matter expertise to execute engineering and clinical batches. • Previous experience working in GMP and aseptic manufacturing environment. • Experience working with single use manufacturing consumables such as bags, tube sets, columns and process manifolds. Specialized Knowledge and 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.

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

We are seeking a highly skilled and motivated Associate to join our Credit Quantitative Research team, specifically within the Public Finance team that focuses on municipal bonds and derivatives. Municipal bonds are credit products that are similar to corporate bonds, except that there are special tax-related features and the issuers are different; example issuers of municipal bonds include local governments and municipalities. This is a unique opportunity and you will be involved in comprehensive analytics, models, and tools used in various trading activities, including Algo municipal bond market making. In addition to traditional quantitative methods, the team is keen to explore and integrate various AI/ML methodologies into our modeling approach. This involves a scientific exploration of innovative techniques, with a focus on developing and deploying proven results in a production setting end-to-end. You need to be a forward-thinking individual who can bridge the gap between cutting-edge research and practical application, ensuring that AI/ML models are robust, scalable, and aligned with business objectives. As an Associate for our Quantitative Research Team, you will have the opportunity to collaborate with cross-functional teams, leveraging AI/ML to enhance our trading strategies and decision-making processes. This is an exciting role for those who appreciate how every part of the business connects well together and are eager to contribute to the evolution of our quantitative research capabilities. **Job Responsibilities:** + Develop, enhance and support quantitative models and analytics for municipal bonds and municipal derivatives. + Collaborate with market makers, traders, and other stakeholders to support trading activities and strategies. + Analyze market trends and large datasets, translating them into actionable insights using various methodologies relevant to the projects. + Design and implement tools and systems end-to-end, ensuring that models and analytics comply with industry best practices. + Foster a deep understanding of how different parts of the business connect and contribute to the overall success of both the individual and the team. + Drive projects with a keen eye from a quantitative research perspective, ensuring they progress in the right direction for long-term success. **Required Qualifications, Capabilities, and Skills:** + A post-graduate degree in a STEM discipline (e.g., Mathematics, Physics, Engineering, Computer Science) with hands on experience in statistical modeling. + Minimum 1-2 years of direct experience in a quantitative research or related role within the financial industry. + Knowledge of fixed-income markets and credit-related products, e.g. corporate bonds, and/or municipal bonds. + Proficiency in working with industrial-strength large code base and working with programming languages such as Python including pandas/numpy. + Excellent analytical skills with a keen attention to detail and a systematic approach to problem-solving, with a willingness to explore new ideas. + Ability to work collaboratively in a fast-paced, dynamic environment, while also demonstrating independent and critical thinking skills, as well as exceptional organizational capabilities. + Strong communication skills to effectively convey complex concepts to non-technical stakeholders. **Preferred Qualifications, Capabilities, and Skills:** + Expertise in time series data modeling, with the ability to experiment with and apply various modeling techniques to enhance predictive accuracy and insights. + Expertise in derivatives pricing, with focus on interest rate and credit products and models. JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. We offer a competitive total rewards package including base salary determined based on the role, experience, skill set and location. Those in eligible roles may receive commission-based pay and/or discretionary incentive compensation, paid in the form of cash and/or forfeitable equity, awarded in recognition of individual achievements and contributions. We also offer a range of benefits and programs to meet employee needs, based on eligibility. These benefits include comprehensive health care coverage, on-site health and wellness centers, a retirement savings plan, backup childcare, tuition reimbursement, mental health support, financial coaching and more. Additional details about total compensation and benefits will be provided during the hiring process. We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation. JPMorgan Chase & Co. is an Equal Opportunity Employer, including Disability/Veterans **Base Pay/Salary** New York,NY $135,000.00 - $200,000.00 / year

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description CORE JOB RESPONSIBILITIES: Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data. Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Assist with clinical study report preparation to include narrative writing Participate in adhoc meetings Qualifications KNOWLEDGE/SKILLS/ABILITIES (KSA's): Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent Oncology experience REQUIRED. Hematology experience is a plus. Protocol authoring is a plus. Data review and medical monitoring of data REQUIRED. Minimum 5 yrs experience in oncology clinical development Excellent written and verbal communication skills and interpersonal skills. Knowledge of clinical trial design, basic statistics, and data review tools Proficient at data interpretation Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions Full understanding GCP and ICH Guidelines Detail-oriented, well-organized Ability to assimilate technical and scientific information quickly Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave) Demonstrated ability to work as part of a team Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I look forward to hearing from you!

Clinical Research Scientist Early Development We are seeking a motivated Clinical Research Scientist to join our Clinical Development team and support the execution of innovative clinical studies. This individual will work closely with senior scientists, physicians, and cross-functional partners to contribute scientific expertise, data insights, and clinical input across multiple programs. Key Responsibilities Assist in the design and development of study protocols and protocol amendments. Contribute to the preparation of clinical and regulatory documents, including sections of INDs, study reports, investigator brochures, and updates for health authorities. Provide scientific input into study tools such as case report forms, statistical analysis plans, and data output specifications. Participate in the review and interpretation of clinical safety and efficacy data;support data monitoring activities throughout study conduct. Collaborate with internal study teams and external partners (CROs, vendors, investigators) to ensure high-quality study execution. Present study progress and scientific updates to project leadership and cross-functional committees. Support preparation of data for abstracts, posters, presentations, and manuscripts. Stay informed on evolving therapeutic landscapes, competitive intelligence, and standards of care relevant to assigned programs. Qualifications Advanced degree in a life science discipline preferred (Pharm.D., Ph.D., or equivalent). 1 3 years of experience in clinical research, with at least 1 year in drug development or industry setting. Background in oncology or hematology is a plus. Strong analytical skills and attention to detail, with ability to interpret and communicate complex data. Excellent organizational, written, and verbal communication skills. Ability to work effectively in a fast-paced, collaborative environment and manage multiple priorities. Willingness to travel occasionally (up to ~20%). Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws. By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities The Analytical Scientist II is responsible for extracting and analyzing samples according to established procedures and SOPs. JOB RESPONSIBILITIES Perform all activities related to processing and analyzing biological samples. Participate in developing and validating bioanalytical methods. Documents the activities related to sample analysis and assist in verifying various documents. Assist in reviewing bioanalytical and method SOPs. Initiate analysis runs using the appropriate instruments and software. Follows-up on result analysis and assists in finding solutions to bioanalytical issues. Assist with the integration and revision of data using specialized computer applications. Assist in eliminating the chemical and biological waste generated by laboratory employees and helps clean laboratory equipment and instruments. Perform support tasks to meet the needs of laboratory users. Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. QUALIFICATION Bachelors or College Degree in Science. Good understanding of bioanalytical processes used in the laboratory. Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel and analytical software. Knowledge of chromatography software. Experience in regulatory context. English level (Quebec specific); required bilingualism includes understanding simple messages and following basic instructions. Relative alternate certification may be considered acceptable. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

At Inductive Bio we're tackling the challenge of making drug discovery more efficient. Chemists spend countless hours combining data, expertise, and intuition to create new molecules that are effective, safe, and work well in the human body. It's a slow, complex process, and the patients are the ones left waiting. At Inductive Bio, we're building an intuitive, collaborative platform, powered by state-of-the-art AI to help accelerate this process. Our platform is already being used on dozens of active drug discovery programs, and adoption is rapidly growing. We are backed by leading investors at the intersection of technology and biotechnology, and our team includes world-class technology and drug discovery experts. After achieving quick adoption via word-of-mouth, we are now expanding our capabilities to build state-of-the-art in silico models for toxicity prediction. We are seeking a senior Toxicologist to serve as our primary subject matter expert in toxicology, with an initial focus on liver and cardiac safety. In this role, you will help shape our scientific offering, ensure that our models are rigorously validated, and guide us toward solutions that have meaningful impact in real-world drug discovery programs. What you'll do: Serve as Inductive Bio's lead subject matter expert in toxicology, with a focus on liver and cardiac safety Guide the development of in silico toxicity models, ensuring scientific rigor, biological relevance, and translational utility Provide toxicology consulting support for partner programs Define the scientific standards, benchmarks, and validation approaches that underpin our toxicology offerings Collaborate with internal machine learning and chemistry experts to translate toxicological principles into predictive models Provide expert input into customer engagements, building credibility and helping to shape solutions tailored to partner needs Stay current on the evolving regulatory, scientific, and technological landscape in preclinical toxicology, bringing insights back to the team Contribute to external scientific presence, including publications, presentations, and conference participation Who you are: PhD in toxicology, pharmacology, or a closely related discipline 15+ years of experience in drug discovery or development with deep expertise in toxicology (preferably in both preclinical and translational contexts) Strong expertise in hepatotoxicity and cardiotoxicity, with familiarity across additional organ systems a plus Proven track record of applying toxicology insights to support decision-making in drug discovery or development programs Excellent communication and presentation skills, with the ability to explain complex concepts to both scientific and non-scientific audiences Experience interacting with regulatory authorities and knowledge of FDA/EMA/ICH guidance a strong plus Collaborative, pragmatic, and entrepreneurial-comfortable working across disciplines in a fast-moving startup environment Working at Inductive At Inductive Bio, we know that the people on the team are what make us great. We offer competitive salary and equity-based compensation; comprehensive healthcare benefits (including dental and vision); and the opportunity to grow along with a rapidly scaling company. We are a passionate, kind, and mature team. Working at a fast-growing startup is not always a 9-5 job, but we believe that our employees should have full lives beyond their career.

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

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.

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_*************