Sterile Compounding Manager

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Company: Hims and Hers Health, Inc.

Location: Los Alamitos, CA 90720

Description:

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.
About the Role:

Reporting to the VP of Sterile Compounding, the Sterile Compounding Manager will be responsible for the strategic development and growth of compounding capabilities, as well as acting as a subject matter expert in the development of new compounded treatments. You will strive to maximize quality and patient safety while dispensing medication in accordance with federal and state pharmacy regulations.

You Will:
  • Directly supervise all pharmacists for adherence to Company Policies and Procedures
  • Indirectly supervise manufacturing technicians for adherence to manufacturing policies & procedures
  • Perform and accurately document compounding procedures, quality assurance/quality control checks, and dispensing of compounded preparations
  • Train and evaluate compounding personnel
  • Review and approve materials for use in compounding
  • Oversee the calibration, maintenance, and use of equipment to compound products and monitor the compounding environment in conjunction with the maintenance team
  • Must have familiarity and experience with all necessary compounding equipment as well as GMP environment
  • Work closely with R&D teams on the development and scale-up of new compounded formulations
  • Maintain a safety-first mindset and ensure precautions are taken in all compounding activities within the lab, including when working with hazardous chemicals in accordance with USP and applicable laws
  • When required, wear all personal protective equipment (PPE)
  • Coordinate with the (PIC), Director of Quality and Operations Manager for personnel, compliance and regulatory matters.
  • Develop and evaluate standard operating procedures for the compounding lab and formulations
  • Follow all state and pharmacy regulations and rules as designated by the California State Board of Pharmacy (BOP) and the Food and Drug Administration (FDA)
  • Maintain a clean and sanitary work environment as mandated by the FDA's rules and regulations
  • Perform other tasks as assigned
  • Knowledge of intermediate modality evaluations and parenteral formulation development.
  • Experience with process design and/or scale-up in a pharmaceutical manufacturing setting.


You Have:
  • Bachelor's Degree in Pharmaceutical Sciences, life science, or equivalent field
  • 8+ years of Pharmaceutical Manufacturing experience
  • 5+ years of people management experience
  • Strong sterile compounding/processing experience
  • Experience in implementing operational processes & systems across all phases of sterile product compounding, including long-acting injectables and sterile liquid/lyophilized products.
  • Demonstrated leadership skills in building high-performing teams and motivating compounders.
  • Relevant experience in pharmaceutical development with exposure to all stages of development (R and D, Pilot scale manufacturing, and commercial).
  • Strong math skills
  • Must be able to undergo respirator fit testing - Full beards or a lot of facial hair may prevent a proper seal for the respirator
  • Must have the ability to work in a fast-paced environment
  • Must be able to lift at least 25 pounds with or without reasonable accommodation
  • Must be able to stand for long periods of time and work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking; for prolonged periods of time
  • Must be able to wear required compounding safety equipment for long periods of time when required.
  • Effective knowledge of cGMP practices and regulations
  • Ability to work flexible shift times
  • Technical writing skills for writing Standard Operating Procedures
  • Proficiency in English, verbal and written
  • Proficiency in Windows based computer systems


Our Benefits (there are more but here are some highlights):
  • Competitive salary & equity compensation for full-time roles
  • Unlimited PTO, company holidays, and quarterly mental health days
  • Comprehensive health benefits including medical, dental & vision, and parental leave
  • Employee Stock Purchase Program (ESPP)
  • 401k benefits with employer matching contribution
  • Offsite team retreats


Conditions of Employment:
  • This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
  • This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
  • Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
  • Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.


We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

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