Cannabis jobs at Biopharmaceutical Research Company
We know of 3 jobs at Biopharmaceutical Research Company as of April 2024, including roles such as Director of Pharmaceutical Operations, and Director of DEA Compliance.
More than 30+ days
Biopharmaceutical Research Company (BRC) is seeking a Director of DEA
Compliance to join our team.
Title: Director of DEA Compliance
Reporting To: CEO
Status: Regular, Full-Time
Direct Reports: N/A
Location: Castroville, California
Job Summary Director of DEA Compliance
BRC is the USA’s first federally legal cannabis pharmaceutical company. The Company produces botanically derived active pharmaceutical ingredients (API) and partners with the nation’s leading researchers and investigators to develop cannabis-based therapeutics to serve patients globally.
Biopharmaceutical Research Company’s Director of DEA Compliance is an experienced, diligent, and knowledgeable Compliance Manager with specific experience and qualifications pertaining to the Drug Enforcement Administration. Reporting to the
Company’s CEO, the Director of DEA Compliance is a key member of the Company’s team and integral to the achievement of the strategic, operational, and financial results of the business.
Responsibilities:
- Ensure personnel compliance with DEA regulations and internationally recognized drug regulations.
- Ensure daily operations comply with the manufacture of substances under the
Controlled Substances Act.
- Interact daily with the CEO.
- Supervise and ensure the proper DEA compliance training of all company personnel.
- Stay up to date on all regulatory DEA compliance issues.
- Input data into regulatory agencies’ compliance web-based systems.
- Prepare the site for and oversee DEA on-site regulatory and third-party audits.
- Maintain expertly organized, easily auditable regulatory files.
- Maintain regulatory correspondence and quarterly and annual filings.
- Support the Quality Director with regulatory guidance.
- Assure DEA compliance with 21 CFR 1300.
- Other DEA-related responsibilities as necessary.
Qualifications:
- 4+ years’ experience in controlled substance manufacturing and or compliance.
- 3+ years’ experience interacting with DEA regulators.
- Experience with office software (e-mails, word processing, spreadsheets).
- 3+ years’ experience in DEA inspections and document review.
- Outstanding English written and verbal communication skills.
- Superior attention to detail.
- Discreet, energetic, and honest.
- Desired, but not required: experience with ARCOS electronic reporting.
- A more junior level applicant may be considered as DEA Compliance Manager
ADDITIONAL REQUIREMENTS:
- Must be 21 years of age or older to apply
- Other duties as may be necessary from time to time.
SALARY AND BENEFITS:
Further information available upon request and execution of an NDA.
Medical, Dental and Vision Coverage. ‘
401K plan.
Equity compensation.
BRC is an Equal Opportunity Employer and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Castroville, CA 95012: Reliably commute or willing to relocate with an employer-provided relocation package (Required)
Work Location: One location
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Director of Pharmaceutical Operations
Biopharmaceutical Research Company
Biopharmaceutical Research Company (BRC) is seeking a VP of Operations to join its fast-growing team.
Title: Vice President of Operations
Reporting To: CEO
Status: Regular, Full-Time
Direct Reports: Multiple Directors
Location: Castroville, California
Description:
BRC is the USA’s first federally legal cannabis pharmaceutical company. The Company produces botanically derived active pharmaceutical ingredients (API) and partners with the nation’s leading researchers and investigators to develop cannabis-based therapeutics to serve patients globally.
The VP of Operations, reporting to the Company’s CEO, is a key member of the
Company’s team and integral to the achievement of the strategic, operational, and financial results of the business. This role will be responsible for ensuring that all departments collaborate to meet client requirements for API and strategic projects.
The VP of Operations will understand the Company’s products and processes, markets, functions and identify key performance indicators, build robust tracking metrics, and provide visibility and leadership toward the achievement of short and long-term operational goals. The VP of Operations will be expected to not only maintain and improve existing processes, reporting and results, but quickly and effectively build new capabilities to the benefit of the Company.
More information about the Company’s activities and strategies in the pharmaceutical manufacturing industry are available upon NDA.
This role demands a strong operational background and the ability to manage multiple key initiatives, processes and cross-functional teams. The VP of Operations will work closely with the following functions: Manufacturing (in-house and contract), Quality,
DEA Compliance, Facilities, Business Development, Planning for both clinical and commercial supply and Translational Research.
REQUIRED EXPERIENCE, EDUCATION AND SKILLS:
- Bachelor’s degree and Advanced Degree.
- Previous 10+ years in the biotech or pharmaceutical sectors, with controlled substances experience and/or botanically produced API, a plus.
- Strong knowledge of Good Manufacturing Practices and FDA requirements.
- Knowledge or background in clinical operations and regulatory affairs
- Excellent oral and written communication skills, including presentation development and delivery
- Detail-oriented, balanced with an ability to work at a strategic level but capable to
“deep-dive” as appropriate
- Proven track record working with a virtual supply chain (CDMOs, packagers, distributors etc.)
- Utilizes critical thinking to troubleshoot issues, work collaboratively with a team to brainstorm solutions, and implement improvement solutions.
- Aptitude to multitask, handling multiple projects simultaneously
- Humble collaborator – must be an excellent team player
- Excited to work in a fast-growing, start-up environment
- Excellent analytical problem solver
- Managing complex projects
- Experience managing multiple teams
KNOWLEDGE AND SKILL:
- Expert in GMPs and FDA regulations
- Deep familiarization with all aspects of the Supply Chain model,
Plan/Source/Make/Deliver for both clinical and commercial products
- Experience or knowledge of ICH/GCP
- Proven aptitude to build and lead strong and effective teams
- Experience in working with Regulatory Affairs on building IND and NDA submissions with focus on the CMC sections
- Experience in and understanding of drug development and pharmaceutical manufacturing process
- Proven management acumen, leadership skills and pharmaceutical industry operational excellence
- Strong and proven project management skills in the pharmaceutical industry
- Ability to meet and surpass deadlines
- Strong focus on operational and commercial details and partnerships
- Execution-focused
- Superb analytical and forecasting skills
- High integrity and ethics
- Passion for BRC’s mission and focus
- Desire to work in a high growth, fast-paced startup environment and wear many hats
RESPONSIBILITIES:
- Ensure the Company meets or exceeds customer and partner requirements, specifications and deadlines
- Work closely with Business Development, Production, Manufacturing,
Compliance, Quality, Regulatory Affairs and Research to ensure the day-to-day operations of the business proceed smoothly and optimally
- Coordinate between multiple departments to ensure the Company delivers product(s) in a compliant and timely fashion to clients and research partners
- Develop and oversee goals and operational forecasting
- Understand and be competent in all operational aspects of the business
- Assist the CEO with strategic planning and growth initiatives
- Oversee all operational aspects of the business
- Via the budget process, ensure Operations is appropriately funded in regards to current and future staffing and capital (facilities and equipment) requirements
- Work closely with the Director of Finance to effectively project and analyze the financing needs of the business.
- Develop and monitor operational performance metrics
- Create, implement, and execute operational processes and systems to foster growth and profitability
ADDITIONAL REQUIREMENTS:
- Must be 21 years of age or older to apply.
- Other duties as may be necessary from time to time.
- BRC is an Equal Opportunity Employer, and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
- Up to 20% travel.
Job Type: Full-time
Pay: $51,000.00 - $170,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Paid time off
- Relocation assistance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
- Self-determined schedule
Apply for this job with Biopharmaceutical Research Company
Apply now →
By clicking the "Apply now" button, you'll be leaving Fazow and going to an external job application page for this company.
Please research all companies before applying. When applying for jobs, you should NOT have to pay to apply.
Fazow accepts no liability or responsibility as a consequence of any reliance upon information on external sites or in jobs listed on fazow.com.
Director of Pharmaceutical Operations
Biopharmaceutical Research Company
Biopharmaceutical Research Company (BRC) is seeking a VP of Operations to join its fast-growing team.
Title: Vice President of Operations
Reporting To: CEO
Status: Regular, Full-Time
Direct Reports: Multiple Directors
Location: Castroville, California
Description:
BRC is the USA’s first federally legal cannabis pharmaceutical company. The Company produces botanically derived active pharmaceutical ingredients (API) and partners with the nation’s leading researchers and investigators to develop cannabis-based therapeutics to serve patients globally.
The VP of Operations, reporting to the Company’s CEO, is a key member of the
Company’s team and integral to the achievement of the strategic, operational, and financial results of the business. This role will be responsible for ensuring that all departments collaborate to meet client requirements for API and strategic projects.
The VP of Operations will understand the Company’s products and processes, markets, functions and identify key performance indicators, build robust tracking metrics, and provide visibility and leadership toward the achievement of short and long-term operational goals. The VP of Operations will be expected to not only maintain and improve existing processes, reporting and results, but quickly and effectively build new capabilities to the benefit of the Company.
More information about the Company’s activities and strategies in the pharmaceutical manufacturing industry are available upon NDA.
This role demands a strong operational background and the ability to manage multiple key initiatives, processes and cross-functional teams. The VP of Operations will work closely with the following functions: Manufacturing (in-house and contract), Quality,
DEA Compliance, Facilities, Business Development, Planning for both clinical and commercial supply and Translational Research.
REQUIRED EXPERIENCE, EDUCATION AND SKILLS:
- Bachelor’s degree and Advanced Degree.
- Previous 10+ years in the biotech or pharmaceutical sectors, with controlled substances experience and/or botanically produced API, a plus.
- Strong knowledge of Good Manufacturing Practices and FDA requirements.
- Knowledge or background in clinical operations and regulatory affairs
- Excellent oral and written communication skills, including presentation development and delivery
- Detail-oriented, balanced with an ability to work at a strategic level but capable to
“deep-dive” as appropriate
- Proven track record working with a virtual supply chain (CDMOs, packagers, distributors etc.)
- Utilizes critical thinking to troubleshoot issues, work collaboratively with a team to brainstorm solutions, and implement improvement solutions.
- Aptitude to multitask, handling multiple projects simultaneously
- Humble collaborator – must be an excellent team player
- Excited to work in a fast-growing, start-up environment
- Excellent analytical problem solver
- Managing complex projects
- Experience managing multiple teams
KNOWLEDGE AND SKILL:
- Expert in GMPs and FDA regulations
- Deep familiarization with all aspects of the Supply Chain model,
Plan/Source/Make/Deliver for both clinical and commercial products
- Experience or knowledge of ICH/GCP
- Proven aptitude to build and lead strong and effective teams
- Experience in working with Regulatory Affairs on building IND and NDA submissions with focus on the CMC sections
- Experience in and understanding of drug development and pharmaceutical manufacturing process
- Proven management acumen, leadership skills and pharmaceutical industry operational excellence
- Strong and proven project management skills in the pharmaceutical industry
- Ability to meet and surpass deadlines
- Strong focus on operational and commercial details and partnerships
- Execution-focused
- Superb analytical and forecasting skills
- High integrity and ethics
- Passion for BRC’s mission and focus
- Desire to work in a high growth, fast-paced startup environment and wear many hats
RESPONSIBILITIES:
- Ensure the Company meets or exceeds customer and partner requirements, specifications and deadlines
- Work closely with Business Development, Production, Manufacturing,
Compliance, Quality, Regulatory Affairs and Research to ensure the day-to-day operations of the business proceed smoothly and optimally
- Coordinate between multiple departments to ensure the Company delivers product(s) in a compliant and timely fashion to clients and research partners
- Develop and oversee goals and operational forecasting
- Understand and be competent in all operational aspects of the business
- Assist the CEO with strategic planning and growth initiatives
- Oversee all operational aspects of the business
- Via the budget process, ensure Operations is appropriately funded in regards to current and future staffing and capital (facilities and equipment) requirements
- Work closely with the Director of Finance to effectively project and analyze the financing needs of the business.
- Develop and monitor operational performance metrics
- Create, implement, and execute operational processes and systems to foster growth and profitability
ADDITIONAL REQUIREMENTS:
- Must be 21 years of age or older to apply.
- Other duties as may be necessary from time to time.
- BRC is an Equal Opportunity Employer, and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
- Up to 20% travel.
Job Type: Full-time
Pay: $51,000.00 - $170,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Paid time off
- Relocation assistance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
- Self-determined schedule
Work Location: One location
Apply for this job with Biopharmaceutical Research Company
Apply now →
By clicking the "Apply now" button, you'll be leaving Fazow and going to an external job application page for this company.
Please research all companies before applying. When applying for jobs, you should NOT have to pay to apply.
Fazow accepts no liability or responsibility as a consequence of any reliance upon information on external sites or in jobs listed on fazow.com.