Scientist - Downstream Process Development
Gaithersburg, MD jobs
Kelly Government Solutions is seeking a Scientist - Downstream Process Development to work on-site with the Vaccine Production Program at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Gaithersburg, MD.
KEY TASKS/SERVICES
(1) Support the Purification group of the Vaccine Production Program (VPP) Labs of the Vaccine Research Center (VRC).
(2) Develop downstream (purification) processes, under the supervision of a project lead scientist, for recombinant proteins, virus vaccines, and virus-like particles (VLP) that may be used as clinical vaccine candidates.
(3) Serve as a functional lead in chromatography process development unit operations.
(4) Provide critical process step assessment and experimental design to define optimal process parameters for chromatography unit operations.
(5) Train team members in large-scale unit operation such as AxiChrom column packing and Pilot-scale chromatography execution.
(6) Work independently and collaboratively within the purification group to design, develop and optimize chromatography and filtration step unit operations to support process development of clinical trial vaccine candidates and mAb products.
(7) Purify research-phase recombinant proteins, virus vaccines and/or virus-like particles in support of other groups at the VRC.
(8) Work to prepare necessary materials (buffers, packed columns, etc.) in support of downstream process activities.
(9) Perform protein/small molecule conjugation experiments to support method development or conjugate-based vaccine candidates.
(10) Support technology transfer of processes to VRC Pilot Plant for manufacture of clinical products including authoring process descriptions, reports, and on-floor support.
(11) Author training documents, process documents and summaries, instrument SOPs, technical reports, protocols, and other supporting documentation.
KEY REQUIREMENTS
(1) Ph.D. in a scientific field with at least 5 years of experience. MS with at least 10 years of specialized experience may also be considered.
(2) Deep understanding of challenges and method development approaches of mAb, vaccine and mRNA scientific field.
(3) Familiarity with monoclonal antibody and multi-specific antibodies, recombinant protein vaccine and nanoparticles; mRNA and mRNA/LNP vaccines.
(4) Analytical skills and applications such as developing release and characterization methods using reversed phase HPLC/or UPLC -UV methods or HPLC/or UPLC - MS methods for pipeline project support.
(5) Experience with other bio-separation techniques such as electrophoresis and lab-on-chip separation.
Associate Principal Scientist, Downstream Vaccines and Advanced Biotechnologies Process R&D
Point, PA jobs
Associate Principal Scientist - Downstream Vaccines and Advanced Biotechnologies Process R&D
Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for all of our company's pipeline. Our Discovery Interface team works closely with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology, and seeks to embed developability/manufacturability considerations into early research discussions in order to enable more seamless and rapid progression of candidates from Discovery into Process Development and Clinical Supply Manufacturing.
We are seeking an innovative, highly motivated, and experienced Associate Principal Scientist to join us at our research and development site in West Point, PA (outside Philadelphia).
The candidate will be responsible for scientific/technical leadership of a downstream/bio-purification process development team, and will also be a critical member of cross-functional program/project teams. This will require frequent collaboration with cross-functional teams including colleagues in Discovery, Analytical, Formulation, and Enabling Technologies. The candidate should have a strong background in recombinant protein therapeutic/vaccine process design and understanding of various purification modalities, including but not limited to column chromatography (SEC, IEX, Affinity, MMC, HIC, etc.) and filtration unit operations (depth filtration, sterile filtration, viral filtration, TFF), as well as advanced knowledge in peptide/protein handling and purification techniques. Alternatively, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Preferably, the candidate will have experience with both recombinant protein purification and conjugation process development.
Primary responsibilities include, but are not limited to:
Lead early downstream process design and development for recombinant subunit and/or conjugate vaccine products.
Contribute to the development of new principles, concepts, methods, and workflows to enable rapid early process development for new molecules emerging from Discovery.
Design, execute, and analyze process development experiments to maximize understanding of recombinant subunit and/or conjugate vaccine production processes, thereby de-risking later stage process/product development.
Represent functional area in cross-functional and strategic teams engaged in novel vaccine development.
Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of downstream/bio-purification process development for vaccines and advanced biotechnologies.
Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.
Analysis of downstream/bio-purification experiments through basic analytical techniques including SDS-PAGE, UV-Vis, HPLC, Light Scattering
Data interpretation and presentation, manuscript/patent preparation
Education Minimum Requirement:
Must have a BS or MS or PhD in engineering or biological sciences
Engineering: Chemical Engineering, Bioengineering, Biomedical Engineering
Science and Technology: Cell Biology, Biological Sciences, Biotechnology
For BS candidates, at least seven (7) years of experience in a pharmaceutical or biotechnology-related position.
For MS candidates, at least five (5) years of experience in a pharmaceutical or biotechnology-related position.
For PhD candidates, at least three (3) years of experience in a pharmaceutical or biotechnology-related position.
Required Experience and Skills:
Must have strong scientific and hands-on understanding of a wide variety of common downstream unit operations for large molecule purification (e.g., depth filtration, chromatography, tangential flow filtration), biotherapeutic and/or vaccine production, and purification process development and sound understanding of scale-up principles.
At least 5 years of hands-on experience in the optimization of downstream processes
Some prior experience with statistical design of experiments (DOE) and/or algorithmic process optimization.
Strong understanding of, or hands-on experience in, cGMP manufacturing.
Ability to work effectively both independently and in a team-focused environment.
Well-developed organizational, record-keeping, and timeline/resource-mapping skills.
Preferred Experience and Skills:
Experience in purification unit operations using AKTA platform (or similar FPLC system)
Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates)
Demonstrated knowledge of peptide and protein biochemistry (e.g., structure, function, immunology), and cutting-edge methodologies related to protein isolation/purification
Experience in mentoring others and leading small technical development teams
Experience in authoring and reviewing CMC regulatory documentation
Experience with process and technology transfer
The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for him/herself and his/her team.
Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Some travel may be required. This position may require occasional off-hour and weekend work.
PRD
Required Skills:
Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Biomedical Engineering, Biomedical Sciences, Biomedical Technologies, Cell Line Development, Column Chromatography, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunoassays, Innovation, Interpersonal Relationships, Laboratory Safety, Leading Project Teams, Machine Learning (ML), Mechatronics, Molecular Biology, Neurotrophins, Pharmaceutical Formulations, Pharmaceutical Process Development {+ 3 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$139,600.00 - $219,700.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at *******************************************************
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/26/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Auto-ApplyScientist II, Discovery, Targeted Therapy
Cambridge, MA jobs
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** .
**Purpose and Scope:**
The Discovery Targeted Therapy Research team at Astellas is seeking a highly accomplished and visionary scientist to drive innovative research initiatives in oncology drug discovery. This role is ideal for a candidate who has a proven track record of successfully designing, executing, and leading discovery-phase research programs targeting cancer biology. The candidate will be responsible for being a member of a research program team to generate new ideas, develop study plans, conduct pharmacology studies, meet timelines, actively engage with global R&D stakeholders, and deliver high-value products.
**Essential Job Responsibilities:**
This position directly impacts our ability to prosecute our company goals of maintaining an early-stage pipeline of potential drug candidates. The measures of success are the advancement of new targets through the successive stages of the drug discovery pipeline. Their components are:
+ **Pipeline Advancement:** Contribute to the strategic expansion of Astellas' oncology pipeline by identifying promising drug targets and ensuring robust preclinical validation aligned with clinical development strategies.
+ **Strategic Program Leadership:** Conceive and manage oncology-focused drug discovery programs from early concept through preclinical development. Collaborate across multi-disciplinary teams including biology, chemistry, translational science, and clinical development to align scientific goals with strategic business objectives.
+ **Scientific Innovation & Execution:** Design and execute research studies that identify and validate therapeutic targets across a range of cancer indications focusing on GI & GU. Apply cutting-edge techniques in molecular biology, cellular assays, and in vivo models to support candidate selection.
+ **Data Analysis & Communication:** Utilize advanced analytical tools to interpret complex biological datasets, derive actionable insights, and present findings to cross-functional stakeholders and leadership.
+ **Cancer Biology Expertise:** Develop deep understanding of tumor biology, resistance mechanisms, and biomarker development. Focus on emerging areas such as targeted protein degradation, synthetic lethality, or immune-oncology strategies to enhance therapeutic efficacy.
+ **Collaboration:** Proactively foster strategic partnerships with leading academic institutions, clinical research centers, and biotech companies to accelerate the discovery of transformative cancer therapies.
**Qualifications**
**Required:**
+ Master's degree (MS) or Doctor of Philosophy (PhD) in relevant scientific field that provides knowledge of theories, principles and concepts within biological sciences or similar discipline.
-MS with minimum 8+ years of drug discovery experience
-PhD with minimum 5+ years of drug discovery experience
+ Proven expertise in molecular biology, biochemistry etc. with competence in designing, developing, and executing wide range of in vitro assays and/or in vivo animal models.
+ Exceptional understanding of mechanisms of cancer maintenance and key signaling pathways in the disease.
+ Experience with advanced molecular biology techniques including CRISPR/Cas9 gene editing, flow cytometry, and cell culture of both, primary tumor cells and established tumor cell lines.
+ Excellent problem-solving skills and the ability to design and execute hypothesis-driven research projects independently.
+ Effective communication skills, with the ability to present complex scientific data clearly to both technical and non-technical audiences.
+ Strong collaborative capabilities, with experience working in multidisciplinary teams to achieve common research goals.
+ Strong organizational, time management, and problem-solving skills with the ability to manage multiple projects and meet deadlines effectively.
+ Able to work productively and to participate in a highly creative and fast-paced environment.
+ Excellent communication and interpersonal skills.
**Preferred:**
+ Strong track record of research productivity as evidenced by high-quality, impactful publications.
+ Experience working with small molecules.
+ Proficiency in evaluating cell signaling.
+ Attention to details with excellent organizational and record keeping skills.
**Working Environment:**
+ This position is based in Cambridge US, MA and will require on-site work 5 days/week.
**Salary Range** : $103,600-$162,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
**Benefits** :
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Company fleet vehicle for eligible positions
+ Referral bonus program
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
\#LI-TR1
Category Cancer Biology
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Scientist/Sr. Scientist Division/Department: Analytical Services, CMC (Chemistry, Manufacturing, and Controls) Reports to: Manager/Group Leader Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Job Summary
The Scientist or Sr. Scientist is responsible for supporting in vitro release Testing /In vivo Release testing on drug products. The scientist's duties include analytical method development/method validation, protocol/report writing, IVRT/IVPT apparatus maintenance and qualification.
Role & responsibilities
1. Hands-on experience in conducting, planning and monitoring In-vitro skin permeation studies and Invitro Release Testing: IVPT/IVRT development, validation, pilot study and pivotal study.
2. Thorough knowledge and complete understanding on FDAs requirement for IVPT studies.
3. Data interpretation and day-to-day troubleshooting related to IVPT studies.
4. Should have experience in review of raw data and protocol/report preparation for development, validation, pilot and pivotal studies.
5. Adhere to compliance and regulatory requirement for in-vitro studies.
6. Implementation and revision of SOP's related to IVRT and IVPT studies.
7. Good Subject knowledge related to Bio-analytical methods/Bio samples analysis and interpretation of bioanalytical data.
8. To ensure routine calibration and preventive maintenances of IVRT and IVPT lab instruments within timelines.
9. Should have experience in writing justification and design of experiments to address Agency's deficiencies on IVRT and IVPT.
10. Review and preparation of all study protocols and reports.
11. Interaction with cross functional team and to meet the project timelines.
12. Comfortable handling and/or working with biological tissues such as human skin .
13. Follow company policies and conduct work according to appropriate Frontage SOPs and comply with GLP/cGMP guidelines.
Essential Duties & Responsibilities
Method development/Validation on IVRT/IVPT testing.
Any other drug product testing work.
Protocol/Report writing, Data Review.
Educational/Training Requirement: bachelor's degree or above
Experience: at least two years of related work experience
Knowledge, Skills, and Abilities (KSAs): Clear communication, organization, and teamwork.
Travel Requirements: 0%
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Scientist, Bioanalytical Services
Exton, PA jobs
Scientist, Bioanalytical Services
Title: Scientist, Bioanalytical Services
Scientist / Bioanalytical Services Essential Functions Run sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment.
Responsibilities:
Perform high-volume sample analysis and/or data analysis, data QC, and data interpretation
Maintain schedule of projects and timelines
Coordinate study activities with Principal Investigator to ensure efficiency and quality
Aid in the preparation of study summaries and/or reports
Maintain the proper level of regulatory compliance for each study, helping to address QA audit findings. Maintain tools, computer programs, and SOPs required for studies
Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities. Follow safety precautions.
Job Requirements:
Experience using Sciex Analyst software, and Watson LIMS, a plus.
Ability to successfully work in a team environment.
Excellent oral and written communication skills. Master's degree in Analytical Chemistry, Biochemistry, Pharmacology or related scientific discipline with 1+ years direct experience, OR Bachelor's degree in same discipline with 4+ years direct experience.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Auto-ApplyScientist- Biologics
Exton, PA jobs
Job DescriptionScientist, Biologics
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Responsibilities:
Primary responsibilities include, but are not limited to the following:
Perform analytical and biological sample testing
• Conduct method development and validation studies
• Perform immunoassay techniques: (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies), with proficiency
• Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays
• Maintenance of instruments, and address technical and instrumental issues
• Assist the Principal Investigator with study conduct
• Maintain study documentation
• Meet regulatory compliance requirements
• Maintain a safe work environment
Requirements:
Bachelor's degree in related scientific discipline or Bachelors degree with relevant experience
• At least 2 years working in a laboratory preferred
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Scientist- Biologics
Exton, PA jobs
Scientist, Biologics Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Responsibilities:
Primary responsibilities include, but are not limited to the following:
* Perform analytical and biological sample testing
* Conduct method development and validation studies
* Perform immunoassay techniques: (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies), with proficiency
* Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays
* Maintenance of instruments, and address technical and instrumental issues
* Assist the Principal Investigator with study conduct
* Maintain study documentation
* Meet regulatory compliance requirements
* Maintain a safe work environment
Requirements:
* Bachelor's degree in related scientific discipline or Bachelors degree with relevant experience
* At least 2 years working in a laboratory preferred
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
*
Scientist- Biologics
Exton, PA jobs
Scientist, Biologics
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Responsibilities:
Primary responsibilities include, but are not limited to the following:
Perform analytical and biological sample testing
• Conduct method development and validation studies
• Perform immunoassay techniques: (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies), with proficiency
• Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays
• Maintenance of instruments, and address technical and instrumental issues
• Assist the Principal Investigator with study conduct
• Maintain study documentation
• Meet regulatory compliance requirements
• Maintain a safe work environment
Requirements:
Bachelor's degree in related scientific discipline or Bachelors degree with relevant experience
• At least 2 years working in a laboratory preferred
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Auto-ApplyScientist II, Discovery, Targeted Therapy
Cambridge, MA jobs
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
Purpose and Scope:
The Discovery Targeted Therapy Research team at Astellas is seeking a highly accomplished and visionary scientist to drive innovative research initiatives in oncology drug discovery. This role is ideal for a candidate who has a proven track record of successfully designing, executing, and leading discovery-phase research programs targeting cancer biology. The candidate will be responsible for being a member of a research program team to generate new ideas, develop study plans, conduct pharmacology studies, meet timelines, actively engage with global R&D stakeholders, and deliver high-value products.
Essential Job Responsibilities:
This position directly impacts our ability to prosecute our company goals of maintaining an early-stage pipeline of potential drug candidates. The measures of success are the advancement of new targets through the successive stages of the drug discovery pipeline. Their components are:
Pipeline Advancement: Contribute to the strategic expansion of Astellas' oncology pipeline by identifying promising drug targets and ensuring robust preclinical validation aligned with clinical development strategies.
Strategic Program Leadership: Conceive and manage oncology-focused drug discovery programs from early concept through preclinical development. Collaborate across multi-disciplinary teams including biology, chemistry, translational science, and clinical development to align scientific goals with strategic business objectives.
Scientific Innovation & Execution: Design and execute research studies that identify and validate therapeutic targets across a range of cancer indications focusing on GI & GU. Apply cutting-edge techniques in molecular biology, cellular assays, and in vivo models to support candidate selection.
Data Analysis & Communication: Utilize advanced analytical tools to interpret complex biological datasets, derive actionable insights, and present findings to cross-functional stakeholders and leadership.
Cancer Biology Expertise: Develop deep understanding of tumor biology, resistance mechanisms, and biomarker development. Focus on emerging areas such as targeted protein degradation, synthetic lethality, or immune-oncology strategies to enhance therapeutic efficacy.
Collaboration: Proactively foster strategic partnerships with leading academic institutions, clinical research centers, and biotech companies to accelerate the discovery of transformative cancer therapies.
Small Molecule Bioanalysis Scientist
Cincinnati, OH jobs
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Analytical Chemistry Scientist to join our Bioanalytical Lab team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
* Develop and validate LC-MS/MS, GC-MS, ICP-MS, HPLC methods for small molecule drugs or drug metabolites and biomarkers;
* Draft study protocols/plans, acquisition methods, and study reports;
* Supervise all phases of bioassays to support pre-clinical and clinical pharmacokinetics, PD Biomarkers;
* Supervise technicians for performing method development, validation, and sample analysis;
* Communicate with internal and external resources for sample receiving, quality control, quality assurance, sponsor correspondence etc.
Qualifications
* PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field;
* Previous experience with small molecule drug and drug metabolites analysis;
* Strong project management, compliance, communication, and people skills;
* Experience with various extraction procedures, such as LLE, SPE, SLE+, immune-capture hybrid extraction, etc.;
* Experience with LC-MS/MS, GC-MS, ICP-MS, HPLC, etc.;
* Direct working experience in Good Laboratory Practices is preferred.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
* Cincinnati Campus Overview
* Flexible work environment
* Competitive PTO packages, starting at 20+ days
* Competitive compensation and benefits package
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Discounts on local sports games, fitness gyms and attractions
* Modern, ecofriendly campus with an on-site fitness center
* Structured career paths with opportunities for professional growth
* Discounted tuition for UC online programs
Awards
* Named a Top Workplace in 2024 by The Cincinnati Enquirer
* Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
* Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Auto-ApplyScientist I
Rockville, MD jobs
**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.
At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
**Brief Job Overview**
This is a hands-on, non-supervisory position in USP's Reference Standards Laboratory. The Scientist I will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. A Scientist I has mastered many common techniques in the laboratory and is able to contribute their own observations and input to difficult projects. The incumbent will provide technical assistance to collaborative testing and the continued suitability for use program by performing analytical tests, reviewing analytical data, and preparing summary reports. The incumbent may execute 90% - 100% of their work at the bench level.
**How will YOU create impact here at USP?**
As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
The **Scientist I** has the following responsibilities:
+ Demonstrates solid scientific approach to analysis in the laboratory.
+ Routinely applies personal experience, academic training, and technical insights - including emerging sciences - to solve complex technical problems within the laboratory.
+ Conducts analysis of reference standard candidates using a broad range of analytical methodologies.
+ Organizes, implements, and evaluates testing of reference standards materials.
+ Records experimental data, ensuring clear and accurate transcription of results and calculations.
+ Reviews literature for analytical test methods, as well as interprets and evaluates data.
+ Executes all testing and analysis of data with excellence and essentially no errors.
+ Demonstrates a strong desire to continue learning and grow personal capability.
+ Pursues, recommends, and implements new approaches or processes to improve laboratory operations.
+ Positively influences project direction by ensuring their own work is congruent with overall direction of laboratory projects.
+ Assists with other testing programs and duties in the laboratory as needed.
**Who is USP Looking For?**
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
+ B.A. /B.S. in Science and 2 years of relevant laboratory experience.
+ Working knowledge of common analytical methods and procedures [examples include: Infrared Spectroscopy (IR), Ultraviolet Spectroscopy (UV), Chromatography (TLC, HPLC, GC)], and expertise in calibrating and operating analytical instruments are required.
+ Extensive understanding of chromatographic analyses, as well as other general analytical chemistry principles required.
**Additional Desired Preferences**
+ Strong communication and presentation skills, both verbal and written.
+ Experience working in the pharmaceutical and/or biotechnology industry is strongly preferred.
+ Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred.
+ Proficiency with electronic documentation systems is strongly preferred.
+ Takes personal responsibility to ensure work is delivered on time and is the highest possible quality.
+ Skills to anticipate, troubleshoot, and solve technical problems.
**Supervisory Responsibilities**
None, this is an individual contributor role.
**Benefits**
USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
**Compensation**
Base Salary Range: USD $58,000.00 - $74,000.00 annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights (**************************** notice from the Department of Labor.
**Job Category** Chemistry & Scientific Standards
**Job Type** Full-Time
Scientist I, IVRT
Durham, NC jobs
Summary of Key Responsibilities: • Conducts experiments under limited supervision and maintains excellent notebook documentation in a GMP/GLP laboratory following Good Documentation Practices and ALCOA principles. • Performs In Vitro Release Testing (IVRT) for topical formulations such as Gels, Creams, Ointments, Films and Ophthalmic Solutions as per customer needs.
• Prepares solutions for IVRT and High Performance Liquid Chromatography (HPLC) analysis such as Mobile Phase and Buffer.
• Calibrates and operates micro and analytical balances for reference standard and reagent weighing.
• Calibrates and operates pH meter for Buffer solution adjustments.
• Operates data acquisitions system Empower 3.
• Compiles data for quantitative analyses using Empower 3 and Microsoft Excel.
• Manages daily activities in the laboratory, including chemical inventory and equipment maintenance and troubleshooting
• Safely handles and disposes of hazardous materials including Category 3 and 4 potent compounds.
• Has capacity to don half face respirator and disposable PPE for hazardous materials.
• Provides support to team members as needed.
• Works with limited supervision and interact with colleagues efficiently.
• Drafts reports, protocols, and methods
• Performs logbook and notebook review
Required Qualifications and Skills:
• B.S. in Pharmaceutical Sciences, Chemistry, Pharmacology, Biochemistry, Biology, or equivalent.
• 1-2 years of relevant laboratory experience, university setting or other (GMP experience is preferred).
• Possesses technical skills including handling of reference standards and topical products.
• Previous experience in dissolution and USP general chapter is preferred.
• Experience with general laboratory instruments.
• Proficiency in Microsoft Office, use of data acquisitions systems, and document management systems.
• Follows instructions meticulously, reads and executes protocols and methods as written.
• Methodical, well-organized, conscientious, and thorough
• Demonstrates logical thinking and attention to detail.
• Has the ability to work with limited supervision and interact with colleagues efficiently.
Auto-ApplyScientist II IVPT
Durham, NC jobs
Summary of Key Responsibilities:
Develop and validate skin permeation and/or LC-MS/MS analytical test methods with minimal guidance from senior laboratory personnel
Carry out laboratory work as directed by senior laboratory personnel
Conduct routine analytical experiments using established analytical methods and procedures
Assist with assembling and review of data packs
Prepare detailed protocols and technical reports for development, validation, and post-validation activities
Conduct experiments by developing new analytical methods or using established analytical methods including in vitro permeation testing techniques and LC-MS/MS
Data entry into spreadsheets, as directed by senior laboratory personnel
For LC-MS/MS experiments independently perform full data review of chromatography, transcription checking of spreadsheets, and calculation review of spreadsheets
For Skin permeation/IVPT experiments transcription checking and calculation review of spreadsheets
Review and maintain laboratory notebooks
Assist in training of entry-level employees
Manage essential laboratory activities including equipment maintenance schedules, chemical and laboratory supply inventory
Required Qualifications and Skills:
B.S with 3-8 years of experience, or M.S with 2-6 years of experience: focus in chemistry, biology, pharmaceutical sciences or related scientific discipline
2-5 years of experience in a GxP laboratory setting in the pharmaceutical industry
Experience in either LC-MS/MS or IVPT/Skin permeation testing, troubleshooting and validation
Demonstrated experience in developing and implementing new technologies, ways of working, and/or tools to improve capability
Technical report writing proficiency
Experience with other general laboratory instruments and wet chemistry techniques
Proficiency in Analyst and/or MassLynx and MS Excel
Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience
Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical
Auto-ApplyScientist I
Frederick, MD jobs
**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.
At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
**Brief Job Overview**
The Scientist I is responsible for the management and handling of Physical Materials (i.e. USP Reference Standards and USP Analytical Materials) queries. This individual responds to customer queries via Salesforce. The Scientist I will work closely with the US-based Technical Services Manager Team Lead as well as teams such as US-based Quality Assurance, Customer Service, Reference Material Support, Reference Standard Technical Operations, Reference Standards Production, Distribution, and Reference Standards Evaluation departments. Candidate ensures maximum goodwill & professionalism with all customers and follows USP's Customer Experience Goal Standards.
**How will YOU create impact here at USP?**
As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
The Scientist I has the following responsibilities:
+ Research queries, formulates responses, and verifies information with relevant colleagues (e.g. RS Scientists, Packaging, Distribution, etc.) and data sources if necessary.
+ Receives and responds to Physical Materials queries received from external stakeholders using the Case Management Module in Salesforce (USP360).
+ Triages cases in the Physical Materials Salesforce queues for the appropriate individual or team.
+ Alert Technical Services management of trends, pain points, and process improvement opportunities.
+ Responsible for maintaining a high level of professionalism with customers and works to establish a positive rapport with them.
+ Stay up to date with industry trends and USP physical material product offerings and changes.
**Who is USP Looking For?**
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
+ Bachelor's degree in a relevant scientific discipline.
+ Experience in a similar role will be considered in lieu of a degree.
+ Minimum of one (1) year of experience working in a pharmaceutical laboratory.
**Additional Desired Preferences**
+ Knowledge of USP standards-setting processes, compendial terminology, and the USP Reference Standards and Materials programs.
+ Ability to multi-task and manage time while handling a large volume of work in a fast-paced environment.
+ Excellent verbal and written communication skills.
+ Sufficient typing skills.
+ Possesses organization skills, problem solving skills, and attention to detail.
+ A customer-centric mindset with a passion for improving customer experience.
+ Able to work flexible hours when needed.
+ Able to establish and nurture relationships with individuals of varying backgrounds.
+ Maintains composure and enthusiasm in stressful situations.
+ Must be able to work independently and in a team environment.
+ Preferred but not required, Experience using Salesforce CRM.
**Supervisory Responsibilities**
None, this is an individual contributor role.
**Benefits**
USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
**Compensation**
Base Salary Range: USD $56,500.00 - $72,000.00 annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights (**************************** notice from the Department of Labor.
**Job Category** Chemistry & Scientific Standards
**Job Type** Full-Time
Analytical Development Principal Research Associate
Boston, MA jobs
Employer: Vertex Pharmaceuticals Incorporated JOB TITLE: Analytical Development Principal Research Associate OPENINGS: 1 * Design, develop, execute and analyze characterization and release assays for identity, purity, strength and potency of cell- based products. Multiple analytical platforms will be employed including RT-qPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry, Flow-cam, dd PCR, Alphalisa and cell- based functional/ potency assays.
* Execute test methods in support of pluripotent stem cell Process Development activities.
* Troubleshoot, optimize, and trend assay performance.
* Report on project progress, write analytical development protocols and reports, provide recommendations to management.
* Identify, qualify, and manage analytical reagents as per regulatory standards.
* Establish assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
* Perform statistical analysis to establish specificity, sensitivity, linear range, precision, and accuracy of test methods.
* Establish reference standard materials as required to support assay validation.
* Transfer assays to QC and provide SME support for assay qualification, author transfer/qualification protocols and reports.
* Maintain excellent written documentation (e.g. lab notebook and test forms).
REQUIREMENTS: Employer will accept a Master's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 2 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.
Alternatively, employer will accept a Bachelor's degree in Biochemistry, Cell & Molecular Biology, Pharmacology and Toxicology or a related field and 6 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.
Position requires demonstrable experience in the following:
Developing analytical methods in compliance with ICH guidelines. Assisting with the following assay platforms: RT-qPCR, ELISA, Western blots, Flow cytometry or cell- based functional/ potency assays. Assisting with the culture of multiple mammalian cell types and combination drug product (Cells + device) Using literature to design proof of concept studies. Writing technical documents including development reports, qualification protocols and qualification reports.
Rate of Pay: $88300.00 - $132400.00
CONTACT: Send Resume to *********************. Reference 12140.579. EOE.
#LI-DNI
Pay Range:
$0 - $0
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Onsite
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyProcess Development, Associate Director - Cell Line Development (CLD), Biologics
Boston, MA jobs
Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics, Cell and Genetic therapeutics.
The successful candidate will bring deep technical knowledge in cell line development and act as the technical lead for CLD work. This is a highly cross-functional role that will work closely with drug substance development, analytical development, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making.
Key Duties and Responsibilities:
* Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities.
* Evaluate, select and manage external capabilities for cell line development.
* Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies.
* Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation.
* Develop and manage project timelines and budget for CLD activites.
* Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals.
* Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer.
* Review and approve technical protocols, development reports, and data packages provided by CDMOs.
* Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners.
* Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD.
* Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.
* Expected travel: 10-20% (domestic and international)
Required Education:
* PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience.
* Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered.
Required Experience and Skills:
* Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins.
* Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred.
* Knowledge of upstream process development and analytical methods related to CLD.
* Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows.
* Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.).
* Proven track record of delivering on complex biologics development programs.
* Excellent interpersonal, communication, and organizational skills.
* Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment.
#LI-LE1
Pay Range:
$166,800 - $250,200
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Onsite
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
Auto-ApplyTALENT PIPELINE - Scientist II (Analytical R&D)- Future Opportunities
Durham, NC jobs
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients.
Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview Thank you for considering a future opportunity with Cambrex! If you are interested in joining our team but don't see a current role that fits your background, please submit your resume here.
If we have future opportunities that match your skillset, we will contact you.
While we are not currently hiring for a role linked to this specific posting, we would love to connect with talented individuals who are interested in potential future positions.
By joining this talent pipeline, you will be the first to be notified when suitable opportunities arise within our Analytical R&D function.
Cambrex's Analytical R&D positions will be on-site at our Durham, NC site.
Responsibilities Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products.
Able to organize routine work with supervision and to evaluate and interpret generated data.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Qualifications/Skills Duties and Responsibilities • Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines • Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.
• Maintains compliant records with little or no supervision • Able to write technical documents with assistance • Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks • Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions • Sets up various instrumentation for testing according to written test methods and with little to no supervision.
• As needed, troubleshoots laboratory instrumentation • Leads a sample project with assistance • May participate in client level meetings, with approval • Responsible for ensuring compliance with cGMP and other regulatory guidelines.
• Analyze information for technical correctness and accuracy • Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor • Perform routine laboratory procedures in a timely and efficient manner • Gain familiarization with analytical techniques • Participate cGMP activities • Maintain laboratory equipment and supplies as directed • May support peer-led laboratory investigations process with assistance • Maintain a clean and safe work-space • Maintain laboratory notebook and/or computer files (i.
e.
LIMS) according to standard, accepted practices • Participate in group and project meetings as required • Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems • Attend seminars as required • Participate in and comply with all current safety, health and environmental programs • Shows initiative and interest in learning new techniques and tests • Participates in technical discussions and brainstorming sessions • Communicates issues or challenges to senior staff and/or management • May review test data acquired by others and witness others' notebooks • Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs • Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed • With guidance, prepares well written and organized development reports • Performs other related duties as assigned.
Education, Experience & Licensing Requirements Skills and Competencies • Working knowledge of experimental design, including chemistry supporting method development • Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC.
• Working exposure to cross functional techniques including organic chemistry.
• Able to comply to SOPs and basic regulatory compliance • Working knowledge of scientific concepts, principles and procedures • Actively and positively engages with team and supports process improvements • Ability to read and execute compendial methodologies • Strong understanding of current FDA and cGMP regulations • General knowledge of chemistry and scientific calculations • Hands on experience in analytical techniques such as HPLC, GC, etc • Good computer skills • Ability to operate laboratory equipment and computers • Ability to take direction from experienced scientists and contributes in a team environment • Good problem-solving skills • Good attention to details • Can repeat and follow detailed scientific procedures with supervision • Able to clearly present results verbally in group meetings and in written progress reports • Good interpersonal skills and is willing to ask questions about procedures and concepts • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations • Good written and verbal communication skills • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.
• Aptitude and willingness to gain more skills & knowledge.
• Good attention to detail and good problem-solving skills.
Education, Experience, and Other Qualifications • B.
S.
/B.
A.
Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience Supervision Received: Works under limited supervision.
Physical Demands, Work Environment, and Travel Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell.
The employee is frequently required to sit.
The employee is occasionally required to stand; walk and stoop, The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required.
Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration.
The noise level in the work environment is usually very quiet.
Travel: Little to no expected travel time.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
#LI-SK1Skills and Competencies • Working knowledge of experimental design, including chemistry supporting method development • Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC.
• Working exposure to cross functional techniques including organic chemistry.
• Able to comply to SOPs and basic regulatory compliance • Working knowledge of scientific concepts, principles and procedures • Actively and positively engages with team and supports process improvements • Ability to read and execute compendial methodologies • Strong understanding of current FDA and cGMP regulations • General knowledge of chemistry and scientific calculations • Hands on experience in analytical techniques such as HPLC, GC, etc • Good computer skills • Ability to operate laboratory equipment and computers • Ability to take direction from experienced scientists and contributes in a team environment • Good problem-solving skills • Good attention to details • Can repeat and follow detailed scientific procedures with supervision • Able to clearly present results verbally in group meetings and in written progress reports • Good interpersonal skills and is willing to ask questions about procedures and concepts • Aptitude and willingness to gain more skills and knowledge in support of GMP regulations • Good written and verbal communication skills • Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.
• Aptitude and willingness to gain more skills & knowledge.
• Good attention to detail and good problem-solving skills.
Education, Experience, and Other Qualifications • B.
S.
/B.
A.
Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products.
Able to organize routine work with supervision and to evaluate and interpret generated data.
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Auto-ApplyMid-Level Embryologist - Wayne, PA
Wayne, PA jobs
RMA of Philadelphia part of the RMA Network of top fertility clinics in the United States is seeking a Mid-Level EMBRYOLOGIST to join our growing team in Wayne, PA. This position will be responsible for executing IVF laboratory procedures according to established policies as well as adhering to RMA's quality assurance/control operating procedures. The ideal candidate will build on previous embryology experience and train to perform all aspects of clinical embryology independently and in accordance with RMA's Laboratory Philosophy, Mission, and Performance Standards.
Responsibilities:
Follow established policies for IVF procedures, specimen handling, and tissue storage
Maintain quality assurance, quality control, and operating guidelines for lab services
Adhere to quality control policies and documentation requirements.
Follow OSHA requirements for safe lab operation
Obtain proficiency to perform all lab services efficiently and reliably on an independent basis
Participate in clinical and research lab operations as directed
Identify problems that may adversely affect patients and facilitate a solution
Participate in lab proficiency testing
Attend laboratory meetings as requested
Attend continuing education programs as requested
Requirements:
Bachelor's of Science
2+ years embryology experience
Demonstrate an aptitude for performance of laboratory services
Aptitude to make appropriate judgments regarding clinical significance of laboratory data
Excellent work ethic and motivation to learn lab procedures
High level of listening and counseling skills
Aptitude to work independently and demonstrate good judgment
Ability to access, input, and retrieve information from a computer.
Knowledge of office procedure and office machines (i.e., computer, fax, copier, etc.)
Must be able to work weekends and some holidays
IVI-RMA offers a comprehensive benefits package to all employees who work a minimum of 30 hours per week.
Medical, Dental, Vision Insurance Options
Retirement 401K Plan
Paid Time Off & Paid Holidays
Company Paid: Life Insurance & Long-Term Disability & AD&D
Flexible Spending Accounts
Employee Assistance Program
Tuition Reimbursement
About IVIRMA Global:
IVIRMA is the largest group in the world devoted exclusively to human Assisted Reproduction Technology. Along with the great privilege of providing fertility care to our patients, IVIRMA embraces the great responsibility of advancing the field of human reproduction. IVIRMA Innovation, as one of the pillars of IVIRMA Global, is a renowned leader in fertility research and science. Check out our websites at: *********************** & ***********************
EEO
“IVIRMA is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: IVIRMA is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at IVIRMA are based on business needs, job requirements and individual qualifications, without regard to race, color, religion and/or belief, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. IVIRMA will not tolerate discrimination or harassment based on any of these characteristics. IVIRMA encourages applicants of all ages.”
Auto-ApplySenior Embryologist - Wayne, PA
Wayne, PA jobs
RMA of Philadelphia part of the RMA Network of top fertility clinics in the United States is seeking a Senior EMBRYOLOGIST to join our growing team in Wayne, PA. This position will be responsible for executing IVF laboratory procedures according to established policies as well as adhering to RMA's quality assurance/control operating procedures. The ideal candidate will build on previous embryology experience and train to perform all aspects of clinical embryology independently and in accordance with RMA's Laboratory Philosophy, Mission, and Performance Standards.
Responsibilities:
Follow established policies for IVF procedures, specimen handling, and tissue storage
Maintain quality assurance, quality control, and operating guidelines for lab services
Adhere to quality control policies and documentation requirements.
Follow OSHA requirements for safe lab operation
Obtain proficiency to perform all lab services efficiently and reliably on an independent basis
Participate in clinical and research lab operations as directed
Identify problems that may adversely affect patients and facilitate a solution
Participate in lab proficiency testing
Attend laboratory meetings as requested
Attend continuing education programs as requested
Requirements:
Bachelor's of Science
2+ years embryology experience
Demonstrate an aptitude for performance of laboratory services
Aptitude to make appropriate judgments regarding clinical significance of laboratory data
Excellent work ethic and motivation to learn lab procedures
High level of listening and counseling skills
Aptitude to work independently and demonstrate good judgment
Ability to access, input, and retrieve information from a computer.
Knowledge of office procedure and office machines (i.e., computer, fax, copier, etc.)
Must be able to work weekends and some holidays
IVI-RMA offers a comprehensive benefits package to all employees who work a minimum of 30 hours per week.
Medical, Dental, Vision Insurance Options
Retirement 401K Plan
Paid Time Off & Paid Holidays
Company Paid: Life Insurance & Long-Term Disability & AD&D
Flexible Spending Accounts
Employee Assistance Program
Tuition Reimbursement
About IVIRMA Global:
IVIRMA is the largest group in the world devoted exclusively to human Assisted Reproduction Technology. Along with the great privilege of providing fertility care to our patients, IVIRMA embraces the great responsibility of advancing the field of human reproduction. IVIRMA Innovation, as one of the pillars of IVIRMA Global, is a renowned leader in fertility research and science. Check out our websites at: *********************** & ***********************
EEO
“IVIRMA is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: IVIRMA is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at IVIRMA are based on business needs, job requirements and individual qualifications, without regard to race, color, religion and/or belief, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. IVIRMA will not tolerate discrimination or harassment based on any of these characteristics. IVIRMA encourages applicants of all ages.”
Auto-ApplyPharmaceutical Physical Properties Scientist
Groton, MA jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
* Analysis of powder samples for key physical properties (such as particle size distribution, bulk density, true density, powder flow, particle shape)
* Analysis of liquid samples for key physical properties (such as viscosity and surface tension)
* Using techniques such as optical microscopy, laser diffraction particle size analysis, electron microscopy, shear cell testing, compaction simulation, etc.
Qualifications
* Bachelor's degree in chemistry or other science related degree concentration, or equivalent directly-related experience
* At least one year experience in particle and powder characterization
* Strong computer, scientific, and organizational skills
* Proficient in learning new techniques, developing and carrying out experimental plans, and performing multiple tasks simultaneously
* Experience in data handling and scientific/engineering computations
* Excellent communication (oral and written) and attention to detail
* Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
* Ability to keep accurate records, follow instructions, and comply with company policies
* At least one year experience in particle and powder characterization
Additional Information
* Position is full-time, Monday - Friday 8am to 5 pm
* Ability to work overtime as required.
* Tasks require repetitive motion and standing for long periods of time.
* May be required to respond to off-shift operational issues.
* Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.
* Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays
* #LI-EB1
* Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.