Associate Scientist jobs at Frontage Laboratories - 428 jobs
Scientist/Senior Scientist
Frontage Laboratories 3.9
Associate scientist job at Frontage Laboratories
Title: Scientist/Senior Scientist
Reports To: Study Director Manager
Company
Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, 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.
Position Summary
We are currently looking for a scientist/senior scientist to be located on-site at our Concord, OH toxicology facility to develop in vitro toxicology assays and new approach methodologies (NAMs). Scientists at Frontage Laboratories serve as technical experts and consultants in in vitro toxicology and related fields, working in a collaborative environment on projects throughout the discovery and development continuum and have a passion for science and quality. The ideal candidate will have knowledge of New Approach Methodologies (NAMs) to replace or reduce the use of animals in drug development and to refine the use of animals to achieve better results.in vitro toxicology. Experience in regulatory toxicology and familiarity with Good Laboratory Practices (GLPs) and drug development is preferred but not required.
Roles & Responsibilities
Knowledge and Experience: Full knowledge of New Approach Methodologies (NAMs) for use in toxicological research and implement NAMs in drug development processes.
Method Development & Validation: Hands-on experience in developing, optimizing, and validating novel in vitro toxicology platforms (i.e., cell cultures, organoids, or high-throughput systems).
Laboratory Execution: Performing experiments using modern instruments including but not limited to flow cytometry and plate readers, etc.
Data Interpretation & Reporting: Interpreting and reporting experimental data; familiarity with computational modeling and statistical analysis.
Scientific and Regulatory Compliance: Ensuring all experimental activities adhere to guidelines and supporting regulatory submissions by providing data that can waive or reduce the need for animal testing.
Collaboration and Communication: Working closely with collaborators; Demonstrating scientific leadership through participation in professional organizations, presentations, and publications.
Additional Responsibilities: Performing additional duties and tasks assigned by the Management.
Qualifications/Requirements:
Master or PhD in cell biological sciences or related fields.
Preferably (3+ years) experience of in vitro toxicology in a CRO, pharmaceutical, or biotechnology setting; however, qualified candidates with other relevant experience are encouraged to apply.
Proficiency in techniques such as cell culture, molecular biology, and biomarker development.
Knowledge of NAMs and AI tools in drug discovery and development.
Strong, effective written and oral communication skills, including the ability to organize and clearly present complex data and concepts.
Ability to work in a fast-paced environment, manage multiple projects, demonstrate consistent productivity, and meet project timelines.
Ability to work independently and collaboratively.
Salary and Benefits
Frontage Laboratories offer a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, short and long‑term disability insurance, life insurance etc.
Concord, Ohio is a township about 30 miles east of Cleveland. The housing is more affordable than many areas close to major cities and is nestled in a rural setting, yet with good restaurants, shopping, and schools within the township. We consider the lifestyle and proximity to attractions in Cleveland to be a hidden benefit of living and working in Concord.
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.
$61k-84k yearly est. Auto-Apply 59d ago
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Lead In Vitro Pharmacology Scientist - GPCR Drug Discovery
Crinetics Pharmaceuticals, Inc. 3.9
San Diego, CA jobs
A biopharmaceutical company in San Diego seeks a Principal Scientist to lead an in vitro pharmacology team. Candidates should have a Ph.D. and over 8 years in drug discovery, particularly with GPCRs. Responsibilities include designing assays, managing a team, and collaborating on research projects. The competitive salary ranges from $158,000 to $197,000, with comprehensive benefits including health insurance and PTO.
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$158k-197k yearly 3d ago
Principal Scientist, Innovation Management, Fremont CA
Boehringer Ingelheim GmbH 4.6
Fremont, CA jobs
Principal Scientist, Innovation Management, Fremont CADescription
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Principal Scientist, Innovation Management will act as a primary expert for upstream/drug substance development and manufacturing with a unique blend of expertise in biopharmaceutical upstream processes, digitalization, and data science. This role will identify and evaluate emerging technologies and companies that can enhance biopharmaceutical manufacturing. The incumbent will provide scientific and technical leadership to the team on both internal and external projects.
Duties & Responsibilities
Ensures direct report (intern & co-ops) safety, training, and supervision.
Responsible for effective management of a team of technical experts. This is an individual contributor Role.
Upstream/Drug Substance Development and Manufacturing:
Leads the development and optimization of upstream processes for biopharmaceutical production.
Oversees cell culture operations, including media development, bioreactor design, and scale-up processes.
Ensures compliance with regulatory standards and quality control measures.
Collaborates with cross-functional teams to integrate upstream processes with downstream and analytical development.
Digitalization and Data Science:
Implements digital tools and data analytics to enhance process understanding and control.
Develops and applies predictive models for process optimization and troubleshooting.
Utilizes machine learning and AI to drive continuous improvement in manufacturing processes.
Manages data integrity and ensures robust data management practices.
Scouting Technologies and Companies:
Identifies and evaluates emerging technologies and companies that can enhance biopharmaceutical manufacturing.
Conducts due diligence and feasibility assessments for potential technology acquisitions or partnerships.
Collaborates with global teams to integrate new technologies into existing processes.
Stays abreast of industry trends and advancements to maintain a competitive edge.
Leadership and Team Collaboration:
Provides scientific and technical leadership to the upstream development team.
Mentors and develops team members, fostering a collaborative and high-performance culture.
Manages project timelines, budgets, and resources effectively.
Represents the company at industry conferences and scientific meetings.
Requirements
BS with ten-plus (10+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field.
OR
MS with six-plus (6+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field.
OR
PhD with three-plus (3+) years' experience in Chemical/Biochemical Engineering, Bioengineering, Biochemistry, Biology, or related scientific field.
Thorough knowledge of biotechnology process development methodologies such as cell culture, aseptic techniques, bioreactor operation and development, column chromatography, filtration, and UFDF.
Knowledge of GMP biopharmaceutical manufacturing, including process validation and commercial manufacturing support.
Four-plus (4+) years' experience in late-stage process development preferred.
Two-plus (2+) years' experience leading in a matrixed environment preferred.
Two-plus (2+) years' experience in data science, Machine learning, and statistical analysis skills
Excellent verbal and written communication skills.
Good documentation and presentation skills.
Proven skills building and maintaining productive relationships with organizational partners such as Manufacturing and Quality.
Ability to troubleshoot and challenge status quo processes and influence in a team environment.
Ability to communicate complex results (e.g. hybrid models) to both internal and external stakeholders.
Eligibility Requirements
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Compensation Data
This position offers a base salary typically between ($115,000) and ($181,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information.
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$115k-181k yearly 3d ago
Principal Scientist, Biopharma Innovation & Digitalization
Boehringer Ingelheim GmbH 4.6
Fremont, CA jobs
A global biopharmaceutical company is looking for a Principal Scientist in Innovation Management. The role involves the development of upstream processes, oversight of biopharmaceutical production, and integration of digital tools in manufacturing. Candidates must have significant experience in biopharmaceutical manufacturing and possess strong leadership capabilities. This exciting opportunity advocates for collaboration, innovation, and a commitment to high-quality standards in a dynamic working environment.
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$134k-180k yearly est. 3d ago
Lead Scientist, In Vitro Antibody Display & Discovery
Eli Lilly and Company 4.6
San Diego, CA jobs
A leading global healthcare firm in San Diego is seeking a highly motivated scientist to contribute to biotherapeutics development. The successful candidate will discover and engineer antibodies, oversee experiments, and utilize various molecular biology techniques. Applicants should have at least 6 years of relevant experience and a strong background in flow cytometry. This position offers competitive compensation ranging from $110,250 to $187,000 along with comprehensive benefits.
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$110.3k-187k yearly 2d ago
Lead Scientist, In Vitro Antibody Discovery
Eli Lilly and Company 4.6
San Diego, CA jobs
A global healthcare leader in San Diego seeks a highly motivated scientist to contribute to the discovery and development of biotherapeutics. The role involves discovering and optimizing antibodies, utilizing flow cytometry, and requires strong skills in molecular biology and biochemistry. Ideal candidates should have significant industry experience and be detail-oriented, with excellent communication skills. Competitive compensation and benefits include a flexible benefits package and bonus potential.
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$120k-159k yearly est. 3d ago
Sr. Microbiologist
Neilmed Pharmaceuticals 4.0
Santa Rosa, CA jobs
NeilMed (Santa Rosa, CA) takes pride in delivering quality OTC products from development through manufacturing.
We're looking for a Senior Microbiologist to join our team and be the subject-matter expert for microbiological control across our manufacturing, QC and operations functions.
Responsibilities
Lead and execute advanced microbiology testing of raw materials, in-process samples, finished goods, packaging materials, and utilities in support of OTC drug manufacturing.
Drive and oversee the environmental monitoring program (clean-rooms, production areas, utilities) and ensure microbiological integrity of the manufacturing environment.
Investigate microbiological failures and out-of-specification (OOS) results; perform root-cause analysis and lead corrective & preventive actions (CAPA).
Develop/validate microbiological methods (e.g., microbial enumeration, microbial limits, preservative efficacy, endotoxin/bioburden, sterility if applicable) aligned with compendial standards (USP/EP) and regulatory requirements for OTC drugs.
Write and review protocols, reports, deviations, CAPAs, trend analyses, change controls and SOPs relevant to microbiology.
Collaborate closely with Manufacturing, Quality Assurance, Regulatory Affairs, R&D and Engineering to create and maintain microbiological control strategies across the product/process lifecycle.
Monitor and analyze microbial trend data and recommend improvements to facility/processes for risk mitigation and continuous enhancement.
Provide technical leadership and mentorship to junior microbiologists/technicians; promote a culture of excellence, data integrity and continuous improvement.
Support internal audits, external inspections, supplier/contract-lab evaluations as required.
Maintain strict adherence to cGMP, GLP, Good Documentation Practice (GDP), and data integrity standards in the lab and manufacturing environment.
Qualifications
Required: Bachelor's degree in Microbiology, Biology or a closely related science (Master's/PhD preferred).
5-10+ years' experience in microbiology within a pharmaceutical/OTC drug manufacturing environment (or similarly regulated manufacturing).
Hands-on experience with microbiological methods: bioburden, endotoxin, sterility (if applicable), preservative efficacy, microbial identification, environmental monitoring (air, surfaces, utilities).
Familiarity with 21 CFR 210/211, OTC monographs, FDA inspections, compendial guidelines such as USP, etc.
Proven experience with method validation, protocol/report writing, deviation/CAPA investigations, trend analysis and root-cause resolution.
Strong leadership, communication and interpersonal skills; ability to train and mentor team members and influence cross-functional stakeholders.
Strong organizational skills, meticulous attention to detail, ability to prioritize tasks and meet manufacturing-driven timelines (including some flexibility for after-hours/weekend support).
Proficiency with LIMS and statistical/data review tools; comfort working in a manufacturing laboratory environment with microbiological cultures, incubators, etc.
Preferred Skills
Experience in vertically-integrated manufacturing operations (raw material → finished goods) and understanding of upstream/downstream impact of microbiology.
Demonstrated track record supporting regulatory inspections or audits (e.g., FDA).
Experience working in an OTC or consumer health product environment.
Strong analytical and problem-solving mindset; ability to influence process improvements based on microbial trend data.
Self-starter attitude and ability to work autonomously within a cross-functional team in a fast-paced manufacturing setting.
Pay range and compensation package
We offer a competitive benefits package including medical/dental/vision.
Retirement plan.
Paid time off.
Opportunities for professional development.
50k Life Insurance Policy (paid by Neilmed).
$87k-132k yearly est. 3d ago
Associate Principal Scientist - Downstream Vaccines and Advanced Biotechnologies Process R&D
MSD 4.6
Point, PA jobs
Applications are sought for an opportunity in the Vaccine and Advanced Biotechnologies (VAX) Process R&D department, which is part of the our Research & Development Division. The individual will support our Company's downstream process development efforts for Vaccine programs at West Point, PA.
Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for our company's pipeline. Our vaccines downstream process development team develops safe, scalable, robust, cost-effective downstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all vaccine modalities.
We are seeking an innovative, highly motivated, and experienced Associate Principal Scientist to join us at our research and development site in West Point, PA. The candidate will be responsible for scientific/technical leadership of a bioconjugation process development team, and will also be a critical member of cross-functional program/project teams.
This role will require frequent collaboration with cross-functional teams including Analytical, Formulation, Process Chemistry, Enabling Technologies, and Manufacturing colleagues. The candidate should have a strong background in downstream bioprocess/bioconjugation design, including reaction steps, filtration (tangential and normal flow) and column chromatography. Preferably, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates).
Primary responsibilities include, but are not limited to:
Lead downstream process design and development for conjugate vaccine candidates.
Design, execute, and analyze process development experiments to maximize conjugate vaccine production processes, thereby de-risking later stage development and tech transfer.
Represent functional area in cross-functional and strategic teams engaged in vaccine development.
Lead tech transfer of vaccine bioconjugation processes for clinical and commercial manufacture.
Serve as scientific/technical mentor for junior staff, providing technical guidance in the various aspects of downstream bioprocess/bioconjugation development.
Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.
Analysis of experiments through analytical techniques including HPLC, light scattering, and spectroscopy.
Data interpretation and presentation, manuscript/patent preparation.
Education Minimum Requirement:
BS, MS or PhD in engineering or bio/chemical sciences:
Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biochemistry, Molecular Biology, Biotechnology
For BS candidates, at least eight (8) years of experience in a pharmaceutical or biotechnology-related position
For MS candidates, at least five (5) years of experience in a pharmaceutical or biotechnology-related position
For PhD candidates, at least three (3) years of experience in a pharmaceutical or biotechnology-related position
Required Experience and Skills:
Strong scientific and hands-on understanding of downstream bioprocess/bioconjugation unit operations, biotherapeutic and/or vaccine process development and sound understanding of scale-up principles.
At least five (5) years of hands-on laboratory experience in downstream bioprocess/bioconjugation development.
Prior experience with statistical design of experiments (DOE) and/or algorithmic process optimization.
Strong understanding of, or hands-on experience in, cGMP manufacturing.
Ability to work effectively both independently and in a team-focused environment.
Well-developed organizational, record-keeping, and timeline/resource-mapping skills.
Preferred Experience and Skills:
Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates), conjugation chemistry and downstream bioconjugate processing.
Experience in leading technical development teams and mentoring others.
Experience in authoring and reviewing CMC regulatory documentation.
Experience with process and technology transfer.
The successful candidate will be expected to demonstrate the ability to communicate results of their work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for themselves and their team.
Position may require working with infectious agents, pathogens, and/or potent compounds with appropriate engineering controls and PPE. Some travel or off-hours work may be required.
#PRD
Required Skills:
Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Bioconjugation, Biomedical Engineering, Biomedical Sciences, Biotechnology, Cell Line Development, Chemical Engineering, Chemical Technology, Column Chromatography, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunochemistry, Innovation, Interpersonal Relationships, Laboratory Safety, Leading Project Teams, Machine Learning (ML), Molecular Biology, Pharmaceutical Formulations {+ 4 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$142,400.00 - $224,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at *******************************************************
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
02/10/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
$62k-87k yearly est. Auto-Apply 10d ago
Scientist II (Formulation Development)
Astellas Pharma 4.9
South San Francisco, CA jobs
**Scientist II** 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 primary purposes of the Scientist II, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT's pipeline. This position will be based onsite in our South San Francisco, CA location.
**Responsibilities**
+ Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use.
+ Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites.
+ Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies.
+ For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data.
+ Evaluate new medical devices or container-closures for local injection products
+ Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work
+ Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately
+ Participate the program meetings to achieve key milestones in a timely manner
+ Regularly present data and conclusions in sub-team meetings
+ Occasionally presents technology summaries to management and program teams
**Required Qualifications**
+ Master's degree (MS) in Biology or Engineering with 8+years of relevant experience in the biopharmaceutical industry
+ Experience in formulation development for biopharmaceutical products
+ Experience in authoring IND, BLAor other related regulatory filings, and responding to agency feedback/inquiries
+ Proven and successful history of taking direction and working independently in a fast-paced environment
+ Positive, professional attitude with a passion for science
+ Outstanding collaboration and problem-solving skills; team player with excellent communication and organizational abilities
**Preferred Qualifications**
+ Experience with process development and technology transfer to GMP facilities for drug product manufacturing process
+ Experience with preparation activities for PPQ of drug product manufacturing processes.
+ Experience in the development of packaging process and transportation validation for drug products
+ Experience in operating basic analytical tools, such as chromatography and electrophoresis
+ Experience working with external vendors, institutions, and other collaborators to develop new and innovative technologies
+ Experience with handling rAAV gene therapy vectors or other viral particles
+ Bilingual: ability to communicate in English and Japanese.
**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 Gene Therapy Technical Dev
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
$103.6k-162.8k yearly 60d+ ago
Scientist II (Formulation Development)
Astellas Pharma, Inc. 4.9
South San Francisco, CA jobs
Scientist II 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 primary purposes of the Scientist II, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT's pipeline. This position will be based onsite in our South San Francisco, CA location.
Responsibilities
* Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use.
* Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites.
* Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies.
* For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data.
* Evaluate new medical devices or container-closures for local injection products
* Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work
* Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately
* Participate the program meetings to achieve key milestones in a timely manner
* Regularly present data and conclusions in sub-team meetings
* Occasionally presents technology summaries to management and program teams
$94k-151k yearly est. 9d ago
Scientist II (Formulation Development)
Astellas Pharma 4.9
South San Francisco, CA jobs
Scientist II
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 primary purposes of the Scientist II, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT's pipeline. This position will be based onsite in our South San Francisco, CA location.
Responsibilities
Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use.
Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites.
Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies.
For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data.
Evaluate new medical devices or container-closures for local injection products
Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work
Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately
Participate the program meetings to achieve key milestones in a timely manner
Regularly present data and conclusions in sub-team meetings
Occasionally presents technology summaries to management and program teams
$94k-151k yearly est. 5h ago
Associate Scientist I LCMS
Alliance Pharma 3.9
Malvern, PA jobs
Responsibilities * Prepare reagents, standards, and control samples * Analyze samples using various techniques specific to department * Assist with method development * Perform method validation or qualification * Operate analytical equipment * Lead troubleshooting activities
* Maintain analytical equipment
* Ensure lab area is clean and inspection ready at all times
* Remove lab waste
* Record tasks in accordance with Good Documentation Practices (GDP)
* Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11
* Follow applicable SOPs and procedural documents
* Review and evaluate data results
* Train lower level Scientists
* Other tasks as assigned
Education, Experience & Skills Required
* BA/BS or higher with 5-6 years lab experience; all experiences will be evaluated
* Able to perform complex lab work
* Able to work in a regulated environment
* Able to work effectively and contribute within a team
* Able to work with computer systems
* Able to document clearly; knowledge of and experience in a regulatory environment
$55k-78k yearly est. 17d ago
Associate Scientist II Immunoassay
Alliance Pharma 3.9
Malvern, PA jobs
Responsibilities * Prepare reagents, standards, and control samples * Analyze samples using various techniques specific to department * Assist with method development * Perform method validation or qualification * Operate analytical equipment * Lead troubleshooting activities
* Maintain analytical equipment
* Ensure lab area is clean and inspection ready at all times
* Remove lab waste\
* Record tasks in accordance with Good Documentation Practices (GDP)\
* Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11
* Follow applicable SOPs and procedural documents
* Review and evaluate data results
* Train lower level Scientists
* Other tasks as assigned
Skills, Education & Qualifications
* BA/BS or higher with 4-6 years lab experience; all experiences will be evaluated
* Able to perform complex lab work
* Experience working in a regulated environment
* CRO experience preferred
* ELISA, MSD experience or pipetting efficiency needed
* Ligand binding/ immunoassay experience
* Able to work effectively and contribute within a team
* Able to work with computer systems
* Able to document clearly; Knowledge of and experience in a regulatory environment
$55k-78k yearly est. 21d ago
Small Molecule Bioanalysis Scientist
Medpace 4.5
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.
$59k-86k yearly est. Auto-Apply 22d ago
AI Scientist
Medpace 4.5
Cincinnati, OH jobs
Do you have a passion for Artificial Intelligence (AI) and are looking to make a difference in how the latest clinical trials progress into the market? Do you have a background in data science and/or computer science with experience working with AI tools for interactive AI applications across various IT systems?
If so, we have an exciting opportunity for you to help take the reins of a groundbreaking project at Medpace.
We are currently seeking a professional with direct experience interacting with artificial intelligence (AI) tools such as NLP, LLM, IA etc. This professional will be expected to lead the programming and fine-tuning of various AI tools and help IT teams to implement them into new applications.
This professional will work collaboratively across the organization with multiple teams to help design the roadmap for how AI can improve efficiency of company processes and provide insights and assistance to users. Applicants should have sufficient technical skills to help lead these types of AI projects independently and to train technical teams for support.
Responsibilities
* Lead the ideation, research, PoC programming and then support programming and fine-tuning of various AI tools with the IT team to implement them into new applications;
* Lead the identification and development of AI tools such as NLP, LLM, and IA;
* Design, develop, and implement artificial intelligence (AI) models and algorithms for various applications;
* Work on a broad set of tasks encompassing various forms of machine intelligence (e.g., machine learning, algorithms, neural networks, computer vision, robotics) to develop AI models for specific applications;
* Train AI models using various algorithms and techniques, optimizing for accuracy, efficiency, and interpretability;
* Deploy AI solutions into production environments, ensuring scalability, reliability, and integration with existing systems;
* Continuously improve models based on feedback and performance metrics;
* Lead AI team activities in educating Medpace AI users in the best development, training and deployment of AI tools including various forms of machine intelligence; and
* Participate in educating, training and development of more junior team members.
Qualifications
* PhD in Artificial Intelligence, Computer or Data Science, or related field;
* Preferably several years of experience working with different AI capabilities and showcasing your passion both at work and outside work in the development of highly complex AI models (NLP, LLMs, Deep learning etc);
* Technical proficiency in programming languages and frameworks commonly used in NLP and AI (e.g., Python, TensorFlow, PyTorch);
* Excellent communication skills to collaborate effectively with cross-functional teams;
* Demonstrated ability to lead projects independently and mentor technical teams;
* A passion for staying up-to-date with the latest advancements in NLP and AI technologies; and
* Analytical thinker with great attention to detail.
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.
$59k-86k yearly est. Auto-Apply 21d ago
Senior Scientist - Formulation Development (R&D)
Nivagen Pharmaceuticals 3.7
Sacramento, CA jobs
Job Description
About the Company:
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Type:
Full Time
Job Location:
Nivagen Pharmaceuticals Inc., Sacramento, CA
About the Job:
Title of the Position: Senior Scientist - Formulation Development
We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry.
Responsibilities:
Lead the design, development, and optimization of complex injectable and sterile dosage forms.
Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA).
Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues
Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives.
Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs.
Define scope, timeline, and resource needs of functional activities and keep team on schedule
Participate in evaluation of new product opportunities.
Ensure timely and high-quality documentation for regulatory submissions.
Stay updated with all FDA and regulatory requirements/guidelines.
Provide mentorship and leadership to team members.
Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance.
Author and review technical reports, protocols, and regulatory documents.
Additional duties and assignments as needed.
Qualifications:
Education/Experience:
Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.
3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.)
Strong understanding of formulation principles, excipients, and drug delivery systems.
Hands-on experience with various formulation techniques and equipment.
Proven track record of successful formulation development and commercialization.
Experience with statistical design of experiments (DOE) and data analysis.
Knowledge, Skills, and Abilities:
Proven track record of successful formulation development for various sterile dosage forms.
Strong leadership, project management, and organizational skills.
Expertise in complex injectable and sterile dosage form development.
Demonstrated ability to conduct independent research and problem-solving.
Requirements:
Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius).
Benefits:
Pay range $70,000-$90,000 per Year
Yearly bonus eligibility
Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
Medical, dental and vision coverage
Paid time off plan
401k savings plan
Additional Information:
Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
$70k-90k yearly 8d ago
Senior Scientist - Formulation Development (R&D)
Nivagen Pharmaceuticals 3.7
Sacramento, CA jobs
About the Company:
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Type:
Full Time
Job Location:
Nivagen Pharmaceuticals Inc., Sacramento, CA
About the Job:
Title of the Position: Senior Scientist - Formulation Development
We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry.
Responsibilities:
Lead the design, development, and optimization of complex injectable and sterile dosage forms.
Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA).
Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues
Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives.
Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs.
Define scope, timeline, and resource needs of functional activities and keep team on schedule
Participate in evaluation of new product opportunities.
Ensure timely and high-quality documentation for regulatory submissions.
Stay updated with all FDA and regulatory requirements/guidelines.
Provide mentorship and leadership to team members.
Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance.
Author and review technical reports, protocols, and regulatory documents.
Additional duties and assignments as needed.
Qualifications:
Education/Experience:
Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field.
3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.)
Strong understanding of formulation principles, excipients, and drug delivery systems.
Hands-on experience with various formulation techniques and equipment.
Proven track record of successful formulation development and commercialization.
Experience with statistical design of experiments (DOE) and data analysis.
Knowledge, Skills, and Abilities:
Proven track record of successful formulation development for various sterile dosage forms.
Strong leadership, project management, and organizational skills.
Expertise in complex injectable and sterile dosage form development.
Demonstrated ability to conduct independent research and problem-solving.
Requirements:
Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius).
Benefits:
Pay range $70,000-$90,000 per Year
Yearly bonus eligibility
Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
Medical, dental and vision coverage
Paid time off plan
401k savings plan
Additional Information:
Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
$70k-90k yearly Auto-Apply 38d ago
Associate Scientist
Zoetis 4.9
San Diego, CA jobs
States considered: CA
Role Description
The Scientist assists in product development, process development and process improvement for the Zoetis Diagnostics product lines in their various platforms including and Lateral Flow, ELISA and PCR technologies. The position includes trouble shooting activities when required by the manufacturing facility. It also includes assisting process improvements of existing products, validation of new processes and transfers of products from R&D and other existing sources. The position also gives support to the Manufacturing group when needed.
Essential functions or specific responsibilities: (What, why, how, percent of time, the planning and analysis required, special assignments, types of decisions, and level of judgment.)
Under the supervision of the GMT Manager, design and perform experiments/studies to mitigate issues from Manufacturing processes.
Assist in developing validation procedures including writing protocols, executing protocols, and participating in validation of materials, suppliers, equipments and processes.
Support the transfer of products from R&D and other manufacturing sources. Transfer and adapt where necessary, manufacturing documents and processes to Zoetis systems.
Provide technical and hands-on support to manufacturing when required.
Perform all work as needed to support USDA license and licensing requirements.
Perform all work required as determined by the GMT Manager
Education and specialized / technical knowledge and skills. (Minimum education, skills and knowledge required.)
BS. degree in a biological science with 1- 3 years relevant experience or equivalent.
Experience with developing and/or manufacturing of diagnostic tests (Lateral Flow, ELISA and PCR,) is highly desirable.
Understanding of statistical tools, such as design of experiments, is desirable.
Must be highly motivated. Able to take directions and work simultaneously on multiple projects is essential.
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in [California] Base pay may vary based on location and other factors.
Base Pay Range: $70,304 - 88,000
[This position is eligible for short-term incentive compensation.]
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
$70.3k-88k yearly Auto-Apply 7d ago
Research Chemist (E&L)
Nivagen Pharmaceuticals 3.7
Sacramento, CA jobs
About the Company:
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Location:
Nivagen Pharmaceuticals Inc., Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834
About the Job:
Title of the Position: Research Chemist (E&L)
We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience.
Responsibilities:
Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems.
Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines.
Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems.
Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing.
Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques.
Interpret complex spectral data and fragmentation patterns.
Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries.
Generate study designs, write protocols, methods, Datasheets and reports.
Provide support in the critical review of analytical data, reports and protocols.
Write Instrument-related SOPs and provide training on the instrument and related software.
Train new recruits in the lab and support the team as needed.
Participate in internal meetings and conferences.
Provide support during technical transfer between R&D and QC.
Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies.
Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions.
Any other activities as directed by the supervisor.
Qualifications:
Education/Experience:
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
Knowledge, Skills, and Abilities:
Familiarity with the characterization and isolation of impurities.
Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques.
Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances.
Skilled in laboratory techniques for measuring, weighing, and handling samples.
Hands-on experience with HPLC (highly preferred).
Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS).
Competency in Microsoft Office applications.
Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred.
Requirements:
Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius)
Benefits:
Pay range $70,000 - $85,000 per Year
Yearly bonus eligibility
Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
Medical, dental and vision coverage
Paid time off plan
401 (k) savings plan
Additional Information:
Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.
$70k-85k yearly Auto-Apply 45d ago
Analytical Chemist
Aerogen 4.4
Foster City, CA jobs
Pharma
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.
We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.
Join us as we embark on this breakthrough and become inspired to deliver.
What is the role?
The person in this role will develop analytical techniques and conduct experiments to support the development of commercially viable lipid-peptide and lipid-protein formulations. In addition, the person will support formulation development efforts. This role is crucial for advancing our CMC program for the Gates project, as well as establishing analytical capabilities and in expertise in our expanding portfolio, ensuring products meet rigorous quality and regulatory standards. The person will be hands on in the lab with strong technical knowledge in analytical science and will be mentored to assist in formulation development efforts.
What are the key responsibilities?
Analytical chemistry: Develop and optimization analytical methods for characterizing and controlling the quality the quality attributes of lipid-peptide and lipid-protein formulations. Support formulation development and design of experiment studies.
Formulation science: Support formulation development efforts by participating in formulation runs with guidance form formulation science staff.
Regulatory Compliance: Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs)
Cross-Functional Collaboration: Work closely with formulation scientists and laboratory management staff, to integrate analytical development within overall project goals.
Troubleshooting & Problem Solving: Address and resolve complex analytical issues during development and manufacturing.
Continuous Improvement: Stay updated on advancements in analytical techniques and industry trends.
What Education and Experience are required?
A degree in Chemistry, Analytical chemistry, Biochemistry or related field.
2-5 years of experience in analytical development or quality control.
Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus.
Experience in technical writing is required.
Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus.
Knowledge and experience in drug-device development, inhalation drug delivery is a plus.
Excellent written and oral communication skills.
What key skills will make you great at the role?
Technical expertise: Proficiency in analytical techniques such as UHPLC, mass spectrometry and CAD as they apply to lipid characterization methods.
Experience with drug-device combination products is a plus. Understanding of laboratory procedures, equipment, software, and data analysis.
Data-driven decisions: Use lab data to make informed decisions about operations, budget, and performance.
Problem-solving and strategic thinking: Quickly and effectively address challenges, from equipment malfunctions to staffing issues. Develop clear strategies and plans to achieve the lab's objectives.
Collaboration and adaptability: Foster a collaborative environment where teams can work together seamlessly. Work well under pressure and adapt to changing priorities in a fast-paced environment.
Compliance and safety: Ensure a safe and complaint work environment.
Training, procedures, quality: Ensure up to date training on procedures and best practices. Ensure the lab meets all relevant quality standards and documentation requirements.
Why Aerogen Pharma?
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.