Aktiv Pharma Group (‘Aktiv’) is a fast-growing, vertically integrated specialty pharmaceutical company with combination products CDMO capabilities, developing, manufacturing, and commercializing sterile-injectable products in a portfolio of proprietary, value-added, prefilled delivery systems. The company’s team of 80 employees harmonize all aspects of combination product development and manufacturing with effectively synchronized operations, including chemistry, device development, manufacturing equipment development, material science, quality and regulatory, in-house cleanroom assembly operations, and in-house sterile fill-finish. Aktiv commercializes drug products independently as well as supporting other pharmaceutical companies address unmet needs and create competitive advantage in the market. Aktiv leading products are proprietary emergency medicine in autoinjectors.

Aktiv’s mission is to deliver peace-of-mind to patients and their communities, and our values are truth, perseverance, caring, and goodness. The company’s culture emphasizes diversity, equity, and inclusivity and implementing leadership across the entire organization. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We believe that our DEI initiatives are an opportunity to make a difference beyond our organization, in our community and society. Aktiv is grateful to be taking part in the individual journey of its employees and is striving to support a balanced life experience. We are striving to create a safe and inviting work place in which our team would be excited to come in the door at the beginning of the work day, and leave at the end of their day with a sense of accomplishment and value.

We are currently hiring for a Aseptic Operations Manager for our Ft. Collins Facility.

The Position: Provide leadership, planning and subject matter expert guidance for the aseptic operations at Aktiv.

Aktiv Pharma Group offers a wealth of benefits to our employees and their families.

Employee Benefits Include:

• The compensation range for the Aseptic Operations Manager is $110,000 - $130,000 annually.
• Medical Insurance (Cigna):
  • HDHP – Aktiv contributes the full monthly premium for the employee and their dependents.
  • Two additional premium medical plan options – Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Vision Insurance (Principal/ VSP Network)
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Dental Insurance (Principal)
  • Low Plan - Aktiv contributes the full monthly premium for the employee and their dependents.
  • High Plan - Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Legal & ID Shield
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Spending Accounts (Rocky Mountain Reserve)
  • FSA
  • HSA
  • DFSA
  • LP FSA
• Ancillary Benefits (Colonial Life)
  • Accident
  • Group Medical Bridge
  • Voluntary Life AD&D
  • Disability
• 401k (Human Interest)
• Unlimited Paid Time Off
• Bi-Monthly Internet and Cell Phone stipend
• Fully Paid Membership for the employee and their dependents to Lifetime Fitness
• Fully stocked office kitchen – Health conscious and Vegan!
• This position will be on location, but flexible work arrangements can be discussed.

Essential Duties/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead aseptic gowning/technique training and aseptic gown qualification activities
• Write and participate in master batch record creation.
• Responsible for identifying training needs within aseptic operations and ensuring training requirements are met.
• Project leader for new products being introduced to manufacturing.
• Source and order manufacturing supplies and process aids.
• Support equipment qualification activities.
• Subject matter expert (SME) for production equipment: leading and supporting training efforts for operators and highly involved with troubleshooting and investigation efforts.
• Aseptic operations SME for: creation of procedures regarding facility cleaning, aseptic technique, operational procedures, and audit support.
• Other duties as required and necessary to ensure the success of the organization.

Supervisory Duties

• Hire, train, supervise, counsel, and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments where appropriate.
• Manage day-to-day activities in aseptic operations.
• Prepare weekly production schedules, communicate and monitor.
• Coordinate activities related to the operations schedule between quality, engineering, development, and third-party contractors.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Excellent knowledge of current Good Manufacturing Practices (cGMP).
• Working knowledge of purchasing, inventory flow, including receiving, issuance to manufacturing and shipping, production planning and scheduling.
• Excellent oral and written communication skills.
• Excellent supervisory and leadership skills.
• Skill in solving diverse and challenging problems.
• Ability to manage multiple projects concurrently and under tight time constraints.

Education and Experience:

• Bachelor’s degree or equivalent experience.
• Five or more years’ experience in manufacturing in a regulated industry preferably in the pharmaceutical industry.
• Minimum three years’ experience in a management role specific to manufacturing.
• An equivalent combination of education and experience may be substituted on a year-to-year basis.

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