Best Formulations Jobs in Usa

JOB TITLE: Assistant Scientist/Engineer

Location: Summit, NJ (100% onsite)

• 10% to 20% of the time in an office environment.

• 80% to 90% of the time in a manufacturing and/or laboratory setting.

• The incumbent may travel between NJ sites Summit and New Brunswick sites to access different laboratories and equipment for the execution of experiments

Duration: 8 months initial (potential extension/potential right to hire)

Work Schedule: Mon-Fri (normal business hours)

The Associate Scientist/Engineer is responsible for supporting studies to establish oral solid formulations. This includes execution of laboratory and pilot plant work, design experimental formulation studies, and conduct material characterization and formulation testing.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

• Knowledge of formulation development.

• Knowledge of data trending and tracking, including use of statistical analysis software a plus.

• Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.

• Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.

Education and Experience:

• Requires a bachelor's degree in science or engineering or related engineering discipline (advanced degree preferred).

• Minimum 0-3 years of relevant work experience

• Previous experience working in formulation development or spray dried dispersion preferred.

• An equivalent combination of education and experience may substitute.

• Experience in oral formulation preparation and testing techniques, including HPLC and dissolution is required.

• Experience conducting material characterization, using DSC and TGA preferred.

Pilot scale batch manufacture with common oral development technologies

General material characterization experience.

DUTIES AND RESPONSIBILITIES:

• Conduct development activities related to developing oral formulations

• Design and optimize formulation using design of experience approach.

• Conduct material characterization and formulation testing.

If hired, you will enjoy the following Eclaro Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to or call (212)804-7476.

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

About Ethel’s Baking Company

Ethel’s Baking Company is a growing specialty bakery dedicated to producing premium gluten-free baked goods that deliver exceptional taste, texture, and quality. By combining traditional baking craftsmanship with modern food science, we develop products that meet the needs of today’s consumers without compromising flavor or indulgence.

Our team is passionate about creating baked goods that everyone can enjoy. Through rigorous research and development, high manufacturing standards, and a strong commitment to food safety, we ensure that every product leaving our facility meets the highest expectations for quality and consistency.

At Ethel’s, we value innovation, collaboration, and continuous improvement. Our employees play a critical role in developing new products, improving processes, and maintaining the high standards that define our brand. We are proud to foster a workplace culture focused on teamwork, accountability, and a shared commitment to excellence.

If you are passionate about great food, quality production, and being part of a team that is redefining gluten-free baking, Ethel’s Baking Company offers an exciting opportunity to grow and make an impact.

Position Summary

The R&D / Product Development Manager is responsible for the development, optimization, and commercialization of gluten-free baked products within a commercial production environment. This role combines hands-on formulation expertise with cross-functional collaboration to deliver high-quality, compliant, and cost-effective products. The position serves as a technical leader and primary execution owner for baking initiatives, supporting business growth through product innovation and continuous improvement.

Key Responsibilities

Product Development & Formulation

• Develop, formulate, and optimize gluten-free & clean label baked goods, including dessert bars, cookies, cakes, and related products.
• Apply food science principles to improve taste, texture, structure, shelf life, and nutritional profiles.
• Evaluate and test ingredients (e.g., alternative flours, starches, gums, fibers, protein, enzymes) for functionality, shelf-life optimization and overall performance.
• Conduct bench-top, pilot, and plant trials to support new product development, process and product improvements.

Scale-Up & Commercialization

• Lead formulation and process scale-up from test kitchen to full commercial production.
• Partner with Operations, Quality Assurance, and Engineering to ensure smooth product launches and ongoing production stability and consistency.
• Troubleshoot formulation, process, and quality issues related to baking performance, yield, and finished product consistency.
• Support continuous improvement initiatives to reduce waste, improve yields, and enhance operational efficiency.
• Support cost reduction initiatives and ingredient sourcing.

Quality, Food Safety & Compliance

• Ensure all R& D and product development activities comply with FDA, FSMA, GMP, GFCO, SQF, Kosher, and applicable state and local regulations.
• Support gluten-free certification requirements, allergen management programs, and cross-contact prevention protocols.
• Assist with label review, ingredient statements, nutrition facts, and product specifications.
• Collaborate with QA to establish and maintain SOPs, product standards, and validation documentation.

Cross-Functional Collaboration

• Work closely with Operations, Quality Assurance, Procurement, Sales, Marketing, and Supply Chain to align R&D priorities and product development with business needs.
• Serve as the primary technical resource for product development projects and production-related challenges.
• Communicate project timelines, trial results, and technical recommendations to management.

Team & Project Leadership

• Provide technical guidance to Production Team and Quality Assurance Team.
• Manage multiple development projects simultaneously, ensuring timelines and deliverables are met.
• Support training of production staff on new products, formulations, and process changes.
• Demonstrate creativity, ingenuity and a passion for baking.

Supplier & Ingredient Management

• Partner with ingredient suppliers to source, evaluate, and validate raw materials.
• Coordinate ingredient trials and maintain technical documentation related to ingredient performance.
• Support cost optimization efforts through ingredient and formulation evaluation.
• Evaluate new technologies, ingredients, and processing methods relevant to gluten-free baking.

Qualifications

Required

• 5+ years of experience in baked goods R&D, with direct experience in gluten-free formulation.
• Proven experience supporting product scale-up and commercial manufacturing.
• Experience in commercial or industrial baking operations.
• Strong understanding of gluten-free systems, ingredient functionality and baking processes.
• Working knowledge of food safety systems (HACCP, FSMA, GMPs), allergen control, and regulatory compliance.
• Ability to work effectively in both test kitchen and production floor environments.

Preferred

• Bachelor’s degree in Food Science, Cereal Science, Chemistry, or a related field.
• Familiarity with gluten-free certification programs and third-party audits.
• Experience in cost modeling, shelf-life testing, and sensory evaluation.

Key Competencies

• Hands-on gluten-free baking expertise.
• Passion for baking and creativity.
• Commercialization and Scale-up execution.
• Practical problem-solving and critical thinking in production environments.
• Strong project management and organizational skills.
• Cross-functional communication and collaboration.
• Technical documentation and process discipline.
• Continuous improvement mindset.

Work Environment & Physical Requirements

• Combination of office, bench-top, and production floor settings.
• Ability to stand for extended periods, lift moderate weights, and wear required PPE.
• Occasional travel to suppliers or manufacturing sites may be required.

Compensation

·      Salary Range: $70K - $85K annually, depending on experience and qualifications.

·      Medical, Dental, Vision Insurance at a shared cost

·      Paid Time Off + Holidays

·      Disability Insurance

·      401k Savings Plan

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Scientist II plays a key role in advancing product development and formulation within the surface care portfolio to support business objectives. This role supports all phases of product development while ensuring adherence to regulatory requirements and quality standards. The Scientist II will collaborate across functions to conduct research, move projects forward, introduce new capabilities, and identify opportunities for continuous improvement. By applying strong expertise in formulation, product development, and regulatory compliance, this position contributes to the delivery of safe, effective, and competitive products that meet market and customer needs. Overall, the Scientist II associate helps drive innovation, enhance operational excellence, and strengthen the organization’s product pipeline.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Research and Innovation:

• Conduct research and experiments in support of innovation and continuous improvement.
• Assist and support in concept development.
• Prepare technical reports, analyze data, and ensure application of strong scientific principles.
• Demonstrate a strong understanding of chemistry and Good Laboratory Practices.
• Awareness of intellectual property concepts including confidentiality, data integrity and invention disclosure. Identifies potentially novel work and contributes with guidance.

Formulation Product Development:

• Formulate and develop new products and technologies based on relevant market insights in support of Environment of care portfolio initiatives.
• Act as R&D Formulation lead in cross functional project teams and support the achievement of key project milestones and deliverables.
• Batch lab-scale formulations and manage stability studies.
• Assist in product scale-up and line trials.
• Provide guidance and support to QC.
• Develop and maintain products in compliance with regulatory and quality requirements.

Product Testing and Analysis:

• Calibrate instrumentation, help troubleshoot equipment, and maintain laboratory supplies.
• Assist in the development and validation of test methods, SOPs and technical documentation.
• Test raw materials, products and prototypes, comparing them to benchmarks or competitor products.
• Analyze data, prepare technical reports, and contribute to scale-up trial report generation.
• Performs root cause, investigation and failure analysis where necessary.

PERFORMANCE MEASUREMENTS

• Progress projects actively through the PDI pipeline, ensuring successful technical output and effective collaboration with cross functional teams.
• Manage multiple project objectives efficiently and adapt to changing priorities.
• Ability to effectively communicate technical findings to both technical and non-technical audiences.
• Demonstrate proactive mindset and strategic thinking in a competitive landscape.
• Ability to foster personal growth and development by utilizing continuous coaching and feedback.

QUALIFICATIONS

EDUCATION/CERTIFICATION

• Bachelor's degree in chemistry (or related field).
• Master's an advantage

REQUIRED KNOWLEDGE

• Previous experience in an R&D lab.
• Familiarity with regulatory guidelines and laboratory procedures.
• Strong understanding of chemistry and Good Laboratory Practices.

EXPERIENCE REQUIRED

• 3-5 years of R&D laboratory experience.
• Hands-on experience with formulation, product testing, and analytical techniques.
• Previous experience with wipes/non-wovens is advantageous
• Previous experience with EPA/disinfectants is advantageous

SKILLS/ABILITIES

• Ability to support key projects through the product development process
• Ability to work independently in the lab and batch lab-scale quantities of specified formulations
• Ability to work on multiple projects of varying complexity
• Strong communication skills (verbal and written)
• Team player
• Good organizational skills and time management skills
• Maintain laboratory supplies and equipment
• Maintain accurate records including laboratory notebooks
• Ability to compile and maintain product Design History Files (DHF)
• Computer literate (Outlook/Word/PowerPoint/Excel)
• Follow safety and lab maintenance procedures
• Adaptable learner
• Enjoys fast pace environment with varied work
• Wants to develop career and make an impact in fast growing and dynamic company
• Proven leadership skills with a diverse group of individuals

SALARY RANGE:

• $75,000 - $85,000 annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

Element is currently seeking an Applications Coating Scientist in the greater Charlotte, NC area.

Our client is a minerals solutions provider supporting various industrial markets.

Currently seeking a Coatings Application Scientist supporting the Applications Development Team. As a Coatings Application Scientist, you will support the innovation in the Paint, Coatings, Adhesives, & Sealants markets through formulation design, evaluation, and engagement with paint and coatings customers.

The successful candidate will have the following Key Accountabilities:

• Identify emerging trends, unmet market needs, and novel opportunities where minerals can create new performance or cost advantages
• Design, execute, and analyze laboratory experiments to evaluate mineral functionality in various coating systems
• Develop prototype products and technical proof-of-concepts demonstrating the value of mineral-based solutions
• Lead the on-going maintenance of the coatings laboratory to support coatings formulation applications
• Conduct the coatings laboratory projects supporting new product development and commercial growth. Develop technical value propositions. Translate voice of customers (VOC) into key performance attributes. Design and conduct experiments to demonstrate and quantify functional and performance benefits using customer language.
• Interface with the technology platform, corporate analytical laboratory, and pilot staff to ensure seamless technology transfer and scale-up.
• Support coatings technical product commercialization, assisting in the creation of technical data sheets, brochures, and new product launch packages
• Support within a cross-functional team to develop IP strategy in the coatings space. Conduct annual coatings IP landscape study, stay up to date to competitive IP.
• Coordinate comparative testing & evaluation of competitive products in the coatings markets.
• Supervise lab technicians.
• Provide training and technical assistance to Sales, Operations, Marketing and other Covia affiliated employees involved in supplying and servicing the coatings markets. Serve as a resource for customer problem resolving and technical support.
• Represent the organization in forums and conferences within specific area of application expertise.

The successful candidate will have the following Minimum Qualifications:

• Bachelor’s degree in chemistry or chemical engineering with 10 years’ experience in the relevant industry, or Master /Ph. D degree with 5 years of industrial experience
• Experience in resin systems and formulations with pigments, fillers, curing agents, activators
• Experience in various paint and coating systems, including architectural interior, exterior coatings, industrial coatings, and specialty applications such as solar reflection coatings.
• Laboratory experience with chemicals, MSDS, ventilation and safety training
• Hands-on ability to execute analytical / laboratory procedures and maintain applicable equipment / systems
• Deep knowledge of coating formulations with a structured methodology for building, optimizing, and testing coating formulations is preferred
• Experience with Critical to Quality (CTQ) process is preferred

Benefits:

• Excellent Healthcare Benefits – medical, vision, dental
• 401K with company matching
• Paid Time Off + Paid Holidays
• Disability plans and Life / AD&D
• Employee Assistance Program

Avantor is seeking a dedicated Sr. Laboratory Technician to optimize our Nusil team, delivering results against some of the most complex business and technology initiatives.

This role will be a full-time position based out of our Carpinteria, CA office. You will have the opportunity to perform laboratory tests, experiments, analyses, prepare and weigh samples for testing and analysis, conduct tests, assays, and other protocols under the direction of a scientist!

What we're looking for:

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• Education: High School diploma or equivalent degree.
  
• Experience: 2-5 years related experience and/or training desired.
  
• Additional Qualifications:
  
• General lab experience in a manufacturing setting preferred.
  
• Understanding of product formulations and basic silicone chemistry desired.
  
• Work with a high level of confidentiality and attention to detail.
  
• Ability to understand, communicate and give complex oral and/or written instructions and follow standard Operating Procedures (SOPs) and GoodLaboratory Practices (GLPs).
  

How you will thrive and create an impact:

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• Ensure all laboratory equipment and work areas are clean, sterile, and in proper working order. May be responsible for calibration of instruments.
  
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  Design and execute experimental plans and calculations associated with basic and advanced test methods.

  
  
  
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  Be knowledgeable of equipment operation, materials formulation, systems use, and lab / pilot processes.

  
  
  
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  Set up advanced laboratory equipment and instrumentation required for experimentation, testing, or process evaluations.

  
  
  
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  Devise experimental plans that are reviewed by senior technical associates prior to execution.

  
  
  
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  Execute experimental work designed by others, making relevant observations & recommendations, enabling the reproduction of results.

  
  
  
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  Maintain functional / practical knowledge of products, intermediates, and raw materials.

  
  
  
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  Check and make adjustments to work methods to solve problems.

  
  
  
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  Document and retain necessary documentation in Agile.

  
  
  
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  Identify & propose/recommend changes to process or formulation based upon comparison of performance to CTQs and previously observed solutions.

  
  
  
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  Identify appropriate testing to properly characterize a material relative to CTQs using existing TMs.

  
  
  
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  Recognize abnormal conditions & results, bringing observations to the attention of project lead(s) in a timely fashion.

  
  
  
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  Assist project lead on development activities and implementing changes to processes, formulations and products.

  
  
  
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  Draft and/or edit new product procedures, providing to project lead for review and routing.

  
  
  
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  Proactively communicate and address technical and timeline challenges in projects.

  
  
  
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  Appropriately update project plans, documenting project progress and communicating with leadership.

  
  
  
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  Provide guidance, coaching, and training to others as needed.

  
  
  

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

The R&D Technologist will play a key role in advancing innovation within a high-volume food manufacturing environment. This position is responsible for supporting research initiatives, developing new product formulations, and improving existing products to enhance quality, efficiency, and cost performance.

Working closely with cross-functional teams, this role supports the full product lifecycle—from early-stage concept development through plant trials and commercial launch. The ideal candidate is technically curious, highly organized, and comfortable operating in both laboratory and production settings.

Responsibilities include but are not limited to:

• Product Development & Commercialization- Developing new food products and product line extensions from concept through commercial production
• Translating bench-scale formulas into scalable production processes
• Conducting plant trials and manufacturing validations to ensure product performance and consistency
• Utilize internal formulation systems to create, update, and maintain product specifications
• Research, Testing & Evaluation- Executing pilot plant trials and prototype testing to validate product concepts
• Analyze data and document results from formulation experiments and processing trials
• Organize internal product evaluations and sensory reviews to support development decisions
• Provide project updates and technical findings to internal stakeholders
• Cross-Functional Collaboration- Partnering with teams across operations, quality, engineering, marketing, and supply chain to support successful product launches
• Regulatory & Technical Documentation- Maintaining detailed records including formulas, project documentation, product specifications, and testing results

Qualification:

• Bachelor’s degree in Food Science, Biology, Microbiology, Animal Science, or related scientific discipline
• 2+ years of experience supporting product development within a food manufacturing environment
• Strong understanding of ingredient functionality and food formulation principles
• Ability to manage multiple projects and meet development timelines
• Strong communication, organizational, and collaboration skills
• (Preferred)Master’s degree in Food Science or related scientific field
• Knowledge of regulatory and food safety standards including USDA or FDA guidelines

Job Purpose:

The Associate will support a Senior Analyst in the Healthcare sector, focused on Biotechnology, with an emphasis on companies where applied chemistry, process development, formulation, and manufacturability (CMC) are key drivers of value. The Associate will conduct primary research and fundamental analysis, build and maintain financial models, and help author differentiated research that translates scientific/technical insights into clear investment conclusions. The ideal candidate is a self-starter with strong analytical rigor, excellent writing skills, and a Master’s-level foundation in Chemical Engineering and applied chemistry.

Duties & Responsibilities:

Research, Diligence & Technical Analysis

• Perform deep diligence on biotech platforms and products where chemistry and process matter, including (as applicable): ADCs, oligonucleotides/siRNA, peptides, radiopharmaceuticals, LNP/delivery systems, biologics formulation, and chemistry-enabled tools.
• Evaluate CMC and scale-up risk across development stages (preclinical through commercial), including:
  • Synthetic route/process complexity, yield/throughput considerations, impurity profiles, stability and degradation pathways
  • Formulation constraints, cold-chain/logistics considerations, and analytical characterization/assay robustness
  • CDMO/manufacturing capacity, tech transfer risk, and timeline sensitivities impacting commercial readiness. 
• Translate technical findings into investment-relevant outputs (e.g., probability-of-success adjustments, timeline shifts, COGS/margin sensitivities, competitive differentiation).

Primary Research & Channel Work

• Conduct primary research through KOL outreach, expert calls, surveys/polling, and other proprietary data collection to support thesis formation and ongoing monitoring.
• Track and synthesize industry trends (pipeline activity, platform adoption, competitive read-throughs, regulatory/CMC expectations) and communicate actionable takeaways.

Financial Analysis & Modeling

• Build and maintain company financial models (forecasting, scenario analysis, valuation work) for use in updates, investment recommendations, and client discussions.
• Incorporate development-stage considerations into models (e.g., stage-based forecasting and key catalyst timing that can shift valuation outcomes).

Writing, Publication & Team Support

• Assist in drafting and publishing research: initiations, earnings notes, catalyst previews/recaps, thematic reports, and breaking-news updates.
• Keep the Senior Analyst informed of daily news flow, filings, data releases, and relevant market developments; propose implications and next steps quickly.

Relationship Management (As You Develop)

• Help maintain and grow relationships with company management teams, industry/academic contacts, internal Sales & Trading partners, and institutional investors.
• Contribute thoughtful questions for management meetings and investor calls, with a focus on chemistry, CMC readiness, and commercialization feasibility.

Requirements & Qualifications:

• Master’s degree in chemical engineering preferred with demonstrated strength in applied chemistry (e.g., reaction engineering, separations/purification, formulation, analytical characterization, process development/scale-up).
• Demonstrated interest in Biotechnology and life sciences investing; ability to connect scientific/engineering details to business and valuation outcomes.
• Strong financial aptitude and willingness to build expertise in modeling, forecasting, and valuation (advanced Excel required).
• Excellent written and verbal communication skills; ability to explain complex technical concepts clearly to non-technical audiences.
• Highly organized, detail-oriented, and able to thrive in a fast-paced, deadline-driven environment.
• Strong work ethic, resourcefulness, and critical/creative thinking.

Additional Skills: 

• 1–3 years of experience in equity research, investment banking, consulting, or biopharma industry roles (process development, analytical development, manufacturing/CMC, QA/QC, or related).
• Familiarity with biopharma development and regulatory context as it relates to CMC (e.g., comparability, stability programs, method validation concepts).
• Experience with scientific literature review and interpreting preclinical/clinical datasets in conjunction with chemistry/manufacturing constraints.
• SIE, Series 63, 86 & 87 preferred (not required upon hiring).

Important Notes:

• Must be authorized to work full time in the U.S., BTIG does not offer sponsorship for work visas of any type
• No phone calls please, the applicant will be contacted within two weeks if successful

About BTIG:

BTIG is a global financial services firm specializing in institutional trading, investment banking, research and related brokerage services. With an extensive global footprint and more than 700 employees, BTIG, LLC and its affiliates operate out of 20 cities throughout the U.S., and in Europe, Asia and Australia. BTIG offers execution, expertise and insights for equities, equity derivatives, ETFs and fixed income, currency and commodities. The firm’s core capabilities include global execution, portfolio, electronic and outsource trading, investment banking, prime brokerage, capital introduction, corporate access, research and strategy, commission management and more.
 
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. BTIG is an equal opportunity employer Minorities/Females/People with Disabilities/Protected Veterans/Sexual Orientation/Gender Identity.

Compensation: 

• BTIG offers a competitive compensation and benefits package. Salary range is based on a variety of factors including, but not limited to, location, years of applicable experience, skills, qualifications, licensure and certifications, and other business and organization needs.
• The current estimated base salary range for this role is $125,000.00 - $150,000.00 per year. Please note that certain positions are eligible for additional forms of compensation such as discretionary bonus or overtime. 

Disclaimer:   

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics

R&D Chemist - Stability Coordinator - Winchester, VA

Winchester, VA - Onsite

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Hubot Tri-Pac, Inc., a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced R&D Chemist-Stability Coordinator to join our fast-growing team immediately. This position is onsite and located in Winchester, VA.

Job Description

The R&D Chemist -Stability Coordinator and stability coordinator is responsible for coordinating and supporting the site stability program, formulation, and stability sampling activities in compliance with the FDA ICH guidelines, company quality guidelines, SOP’s and other regulatory requirements. This position will be required to work well with the cross-functional teams and will be the key point of contact for all stability programs for OTC, Medical device, and Cosmetic products.

Responsibilities

• This will include initiating stability studies, coordinating stability pulls, making sure the testing schedule of stability samples is met, analyzing stability data, and evaluating trends, and writing stability reports.
• To author stability protocols, interim reports, and reports for stability studies
• This includes routine campaign stability studies and non-routine project stability studies.
• Report the trending of stability data through data management and trend analysis using appropriate software.
• To escalate any trends to the R&D Manager and support any investigations, based on the test data collected.
• To support the business in requests relating to stability data (including temperature excursion assessments, regulatory requests, and investigational work)
• To own and support stability related Deviations, CAPAs and Change Controls, and progress department improvements.
• Manage stability studies following internal procedures, ensuring studies are set up per the protocol.
• The Stability Coordinator will interact with other groups in R&D and other departments (such as QC and production) as required.
• Will collaborate with relevant QC laboratories to ensure stability samples are tested within their specified time frame for actives, and micro.
• Coordinate the shipment of stability samples to outside labs when required.
• Maintain stability tracker for routine annual stability and lab stabilities.
• Good knowledge about lab equipment/test – Viscosity; pH; specific gravity; API’s etc.
• Knowledge of cGMP regulations; GLP.
• Support R&D lab with formulation development for OTC; Cosmetic and Medical device in different forms – Aerosol; liquid and BOV.
• Improve current product formulations.
• Lead formulation development activities with a focus on stability as the primary responsibility.
• Proficient in Microsoft office 365.

Education And/or Experience

• Associate or bachelor’s (B.A or B.S) in a scientific discipline; and 2 or more years related experience and/or training; or equivalent combination of education and experience.
• Must demonstrate knowledge of common analytical tools and techniques.
• Must have previous experience with conducting stability studies and knowledge of statistics.
• Must have previous experience in a GMP environment.

Benefits

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term), and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

you for your interest and consideration of a career with Tri-Pac, Inc.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer