Chief Scientist

Description: Connecting People, Plants & Planet to Create Healing Gaia Herbs takes pride in fostering a collaborative workplace where inspired sessions are the norm, and pitching in to support team success is required.
We actively seek out team players who value mission-driven work and love bringing purpose to what we do every day.
Gaia Herbs is growing, and as the leading Herbal Supplement company, we feel an ever-increasing responsibility to contribute to a more inclusive and sustainable economy.
This is why our status as a Certified B Corporation is so important as we continue building exceptional teams who create great products, all while being great stewards of our farm and our planet.
We would love to be your next GREAT employer! Job Summary The Chief Scientist is accountable for the Quality Control and Research and Development teams.
The Chief Scientist is responsible for overall regulatory compliance of the organization and all compliance-related items (i.
e.
Current Good Manufacturing Practices, Certified Organic practices and Alcohol, Tobacco and Firearms Tax and Trade Bureau regulations), including controlled documents, specifications, procedures and quality control testing, as these relate to manufacturing, testing, packaging, labelling and holding operations at Gaia Herbs.
The Chief Scientist is accountable for development and validation of analytical methods, bench-top and pilot-scale manufacturing of new and reformulated products, clinical trials, and master formulas.
Essential Duties and Responsibilities Directs the Quality Control Operations management team: Review and Approval of all Standard Operating Procedures (SOP), Master Manufacturing Records (MMR), Batch Production Record (BPR), packaging materials and other compliance related procedures/documentation Disposition decision on all cGMP (Current Good Manufacturing Practice) materials utilized at Gaia Herbs Develop specifications for all cGMP materials Disposition decision on all materials that require additional investigation such as material review, out-of-specification reports and reprocessing Qualifying all 3rd party partners Corrective Action/Preventive Action (CAPA) investigations Review of all returned products, product complaints, and adverse events Ensure records and materials are retained per the regulations Issues Master Production Formulas for new and reformulated products Oversight of Master Control document control system Directs the Quality Control Laboratory management team: Ensure testing is completed on all cGMP materials Review all data to ensure test methods/SOPs were followed and all control parameters were met Maintain all test methods/SOPs for all laboratory tests/equipment Ensure all laboratory equipment is calibrated Lead investigations into out-of-specification materials Qualify 3rd party laboratories Oversees ISO certification program Directs the R&D Operations team: Conducts benchtop and pilot activities to develop and scale up new and reformulated product projects in collaboration with Operations and Formulation teams Supports internal and external production teams to qualify new ingredients, formula changes and process improvements Perform stability studies to ensure justification of expiration period Manage clinical trials through CROs Develops and validates analytical methods Leads Regulatory team: Serves as primary point of contact for FDA and other regulatory agencies Oversees process for maintaining regulatory approval for FDA and any other relevant certifying bodies pertaining to COG, Non-GMO, ISO, etc.
Conducts review of labelling and Marketing collateral to maintain DSHEA compliance and quantify risk ratings Collaborates with outside organizations on science-related matters, such as clinical research, third-party analytical testing facilities, contract manufacturers, and raw material suppliers Identifies research testing and production inefficiencies and makes strategic recommendations to improve efficiencies Maintains department budgets and reports on budget variance Manages the change control process Leads and assists quality investigations such as CAPAs (Corrective Actions and Preventive Actions), deviation reports, material reviews, and out-of-specification reports Collaborates with Operations to improve quality related metrics and KPI’s Performs duties as Sanitation Supervisor Reviews the quality control data and trend reports with the QC Lab Manager and QC team members Supervisory Responsibilities - Manages the following positions: Director of Regulatory Affairs Director of R&D Innovation QC Operations Managers QC Lab Manager Clinical R&D Manager Requirements: Qualifications Education and/or Experience B.
S in a relevant scientific or regulatory field (e.
g.
, chemistry, biochemistry, pharmacology, pharmacognosy) with a minimum fifteen (15) years of multidisciplinary industrial laboratory experience at the analyst level or above or fifteen (15) years of regulatory experience in a cGMP environment.
Minimum of eight (8) years of laboratory or quality management experience.
Or M.
S in a relevant scientific/regulatory field with a minimum twelve (12) years of multidisciplinary industrial laboratory experience at the analyst level or above or twelve (12) years of regulatory experience in a cGMP environment.
Minimum of six (6) years of laboratory or quality management experience.
Or Ph.
D.
in a relevant scientific/regulatory field with a minimum eight (8) years of multidisciplinary industrial laboratory experience at the analyst level or above or eight (8) years of regulatory experience in a cGMP environment.
Minimum of four (4) years of laboratory or quality management experience.
Knowledge, Skills and Abilities Strong leadership skills with the ability to guide a team of managers, associates and reviewers Expertise in cGMP regulations Expertise in investigations and root cause analysis Expertise in analytical and natural product chemistry Ability to serve as an external expert voice for the organization through publication and potential speaking engagements.
Ability to read and comprehend simple instructions, test methods, standard operating procedures, and memos Ability to write details in a technical manner and to summarize results Ability to develop specifications for materials, components and finished products Demonstrated skill in generating, analyzing and interpreting complex data to draw conclusions, make decisions and prove/disprove hypotheses.
Ability to interpret guidance documents and audit findings to develop internal procedures Ability to train employees on established procedures in one-on-one or small group settings Ability to effectively present information in one-on-one and small group situations to customers, clients and other employees of the organization Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals Ability to compute rate, ratio and percent and to draw and interpret graphs Ability to read and comprehend simple instructions, short correspondence and memos Ability to write simple correspondence Our Perks & Benefits Offered: Medical, Dental, and Vision Insurance starts the 1st day of the following month you’re hired.
Wellness discounts on health insurance Health savings account PTO, sick leave, paid holidays Volunteer time off Voting time off 401(k) - 100% match up to 3% Annual Incentive Plan (Bonus) Equity Shares Recognition programs Gaia product discounts and partnering company discounts with Thrive, Prana, Dr.
Bronner’s Gaia swag and Birthday honey from the Gaian bees Healthy lunches cooked by our company chef using Gaia’s herbs, veggies and local organic meats.
Free farmer’s market during season from Gaia’s own 350-acre farm.
Physical Demands 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 stand and walk.
The employee is regularly required to sit; use hands to finger, handle, or feel; and reach with hands and arms.
The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl, talk or hear; and taste or smell.
Specific vision abilities required by this job includes the ability to pay attention to detail.
Work Environment While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts.
The noise level in the work environment is usually low.
Equal Employment Opportunity has been, and will continue to be, a fundamental principle at Gaia Herbs, Inc.
, where employment is based upon personal capabilities and qualifications without discrimination based on race, color, religion, gender or gender identity, age, national origin, sexual orientation, physical or mental disability, veteran status, or any other protected characteristic as established by law.
All employees and applicants will be treated fairly, with dignity and respect, in accordance with, and as defined by federal, state and local non-discrimination laws.