Bausch Health Companies
Senior Principal Scientist
Bausch Health Companies, Petaluma, California, United States, 94954
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, and medical aesthetic devices. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.
We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action-oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.
We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
DESCRIPTION OF JOB:
Creates and executes extensive analytical and CMC development plans for pharmaceutical active ingredients, excipients, oral and topical drug products. Provides clear and in-depth understanding of ICH guidelines and pharmacopeial requirements (USP, EP, etc.) and their applications to early stage development through commercialization of oral/topical dosage forms and to support regulatory submissions. Performs data assessment and creates DOE using statistical software, such as JUMP or Minitab, to provide extensive analytical support to product development studies, method development studies, and shelf-life assessments. Designs and executes solid state characterization studies or impurities identification/characterization using various analytical techniques such as HPLC/UPLC, LCMS, XRD, NMR, DSC/TGA, etc. Designs and executes dissolution method development and dissolution profiles characterizations for the different types of oral dosage forms. Creates and designs experiments in accordance with QbD/aQbD principles. Designs and executes CMC studies to support product specifications profile development and stability assessment.
Organic chemistry working knowledge is desirable, for recognition of potential degradation pathways, drug-excipient interactions, and for structure elucidation of unknown degradation products/impurities to support pharmaceutical development. Has good communication skills, is well organized and adept in identifying key project steps and corresponding timelines/deliverables. Monitors the scientific progress and budget of assigned projects. Prepares protocols and technical reports. Ensures that laboratory work under the job candidate’s direction is scientifically sound and meets project objectives. Experienced in GMP and GLP, working with regulatory agencies for successful NDA and ANDA submissions. Follows and trains members on safety requirements for the site.
PRIMARY RESPONSIBILITIES
Serves as primary technical consultant/advisor for other scientists and management
Identifies and creates experimental study designs
Directs laboratory work and ensures deliverables
Prepares technical proposals and project budgets
Provides project leadership including technical progress and financial review
Prepares technical reports
Trains individuals and develops training programs
Supervises laboratory staff
Conducts laboratory investigations for anomalous results in a compliant and thorough manner
QUALIFICATIONS
Serves as a technical expert for pharmaceutical analysis
Directs physical, wet chemical, and instrumental analysis
Keeps current in new analytical capabilities and advises management on industry trends and business opportunities
Provides expert interpretation of laboratory results and designs experiments
Prepares analytical reports and documentation for regulatory filings
Good working knowledge of the pharmaceutical industry and regulatory requirements
Ability to exercise independent judgment based on the individual’s specialized skills in pharmaceutical analysis
Good laboratory technique and able to train others
Advanced troubleshooting and method development skills
Technical project leadership abilities
Safety-minded in performance of duties
Quality-minded with ability to perform work with accuracy and in accordance with established procedures
Effectively communicates with Manager, team members, and Senior Management
Organized and able to perform duties in a timely manner
Analytical
Innovative
EDUCATION REQUIREMENTS
Bachelor's or Master's degree in chemistry or related scientific field required with approximately 15+ years of experience in pharmaceutical analysis. Preferred: PhD degree in chemistry or related scientific field with ten plus years of experience in pharmaceutical analysis.
As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $130-175k.
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
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We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action-oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.
We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
DESCRIPTION OF JOB:
Creates and executes extensive analytical and CMC development plans for pharmaceutical active ingredients, excipients, oral and topical drug products. Provides clear and in-depth understanding of ICH guidelines and pharmacopeial requirements (USP, EP, etc.) and their applications to early stage development through commercialization of oral/topical dosage forms and to support regulatory submissions. Performs data assessment and creates DOE using statistical software, such as JUMP or Minitab, to provide extensive analytical support to product development studies, method development studies, and shelf-life assessments. Designs and executes solid state characterization studies or impurities identification/characterization using various analytical techniques such as HPLC/UPLC, LCMS, XRD, NMR, DSC/TGA, etc. Designs and executes dissolution method development and dissolution profiles characterizations for the different types of oral dosage forms. Creates and designs experiments in accordance with QbD/aQbD principles. Designs and executes CMC studies to support product specifications profile development and stability assessment.
Organic chemistry working knowledge is desirable, for recognition of potential degradation pathways, drug-excipient interactions, and for structure elucidation of unknown degradation products/impurities to support pharmaceutical development. Has good communication skills, is well organized and adept in identifying key project steps and corresponding timelines/deliverables. Monitors the scientific progress and budget of assigned projects. Prepares protocols and technical reports. Ensures that laboratory work under the job candidate’s direction is scientifically sound and meets project objectives. Experienced in GMP and GLP, working with regulatory agencies for successful NDA and ANDA submissions. Follows and trains members on safety requirements for the site.
PRIMARY RESPONSIBILITIES
Serves as primary technical consultant/advisor for other scientists and management
Identifies and creates experimental study designs
Directs laboratory work and ensures deliverables
Prepares technical proposals and project budgets
Provides project leadership including technical progress and financial review
Prepares technical reports
Trains individuals and develops training programs
Supervises laboratory staff
Conducts laboratory investigations for anomalous results in a compliant and thorough manner
QUALIFICATIONS
Serves as a technical expert for pharmaceutical analysis
Directs physical, wet chemical, and instrumental analysis
Keeps current in new analytical capabilities and advises management on industry trends and business opportunities
Provides expert interpretation of laboratory results and designs experiments
Prepares analytical reports and documentation for regulatory filings
Good working knowledge of the pharmaceutical industry and regulatory requirements
Ability to exercise independent judgment based on the individual’s specialized skills in pharmaceutical analysis
Good laboratory technique and able to train others
Advanced troubleshooting and method development skills
Technical project leadership abilities
Safety-minded in performance of duties
Quality-minded with ability to perform work with accuracy and in accordance with established procedures
Effectively communicates with Manager, team members, and Senior Management
Organized and able to perform duties in a timely manner
Analytical
Innovative
EDUCATION REQUIREMENTS
Bachelor's or Master's degree in chemistry or related scientific field required with approximately 15+ years of experience in pharmaceutical analysis. Preferred: PhD degree in chemistry or related scientific field with ten plus years of experience in pharmaceutical analysis.
As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $130-175k.
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
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