Sterile Compounding Manager
Sterile Compounding Manager
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Salary Not Disclosed
1 Vacancy
Job 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 were 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/about and hims/howitworks . For information on the companys outstanding benefits culture and its talentfirst flexible/remote work approach see below and visit www.hims/careersprofessionals.
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 compounding personnel
Perform and accurately document compounding procedures quality assurance/quality control checks and dispensing of compounded preparations
Manage train and evaluate compounding personnel
Knowledge of intermediate modality evaluations and parenteral formulation development.
Experience with process design and/or scaleup in clinical or commercial settings.
Review and approve materials for use in compounding
Oversee the calibration maintenance and use of equipment to compound prescription orders and monitor the compounding environment in conjunction with the maintenance team
Must have familiarity and experience with all necessary pharmacy and compounding equipment as well as GMP environment
Work closely with R&D teams on the development and scaleup of new compounded formulations
Follow all safety CFR 210 and 211 BOP and FDA 503B guidelines for the preparation of compounded medications.
When required wear all personal protective equipment (PPE)
Must have knowledge of all principles theories and laws policies and procedures that pertain to compounding specifically CFR 210 and 211 USP <797> USP<800> other USP general chapters and best compounding practices
Develop and evaluate standard operating procedures for sterile 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 FDAs rules and regulations
Complete pharmacy operational requirements by organizing and directing technicians workflow verifying their preparation and labeling of pharmaceuticals
Protect patients and technicians by adhering to infectioncontrol protocols
You Have:
Bachelors 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 longacting injectables and sterile liquid/lyophilized products.
Demonstrated leadership skills in building highperforming 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 fastpaced 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 fulltime 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 (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these . 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 (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity carcinogenicity and reproductive effects) of handling hazardous .
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match.
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 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 ourGlobal Candidate Privacy Statement.
Required Experience:
Manager
Employment Type
Full-Time
