When it comes to providing new hope and a new path to wellness, specialty pharmacy companies like Avella fill a unique and important role. Avella, now part of the Optum and UnitedHealth Group family of businesses, is bringing breakthrough medications, innovative clinical pharmacy programs and technological tools to providers and their patients across the nation. We create a viable level of access to many of the newest, most advanced medications in addition to a suite of tools that include mobile apps, text messaging tools and smart pill bottles. Whether you bring a clinical or business background to our opportunities, you can be sure that you'll be making a meaningful contribution to important solutions and services. Find out more about how you can start doing your life's best work.(sm)
We are currently seeking a Director, Laboratory Operations to join our growing team! This Houston, TX based position has the responsibility for general management and metrics of Avella’s centralized analytical and microbiologic testing lab facility. The position will be directly responsible for all workflow in the facility including technical support to non-sterile microbiologists, sterile microbiologists and analytical chemists. The position will be responsible for all day to day process throughputs, validations, training, staffing and financials / budgeting. The position will work collaboratively with the VP, Quality on all quality / compliance initiatives as well as with the VP, Operations for all growth initiatives for the site and provide executive summaries of such as applicable.
- Primary function is to establish, maintain and manage day to day site laboratory operations
- Work with VP, Quality and VP, Operations to launch and validate the new facility and corresponding process workflows. Scope to include staffing structure, training of all employees and current laboratory transfers to new site
- Oversee non-sterile microbiology testing including, but not limited to, endotoxin testing, environmental and personnel monitoring testing, growth promotion testing and bioburden testing
- Oversee sterile microbiology testing including, but not limited to, sterility testing by mean of membrane filtration as well as rapid testing technologies
- Oversee analytical chemistry testing including, but not limited to, identification, potency, stability (forced degradation) and sub visible particle testing
- Perform function(s) and task(s) that strictly adhere to GLP, cGMPs and company’s policies & procedures
- Establish site specific policies & procedures, as applicable
Assist in annual product reviews and tracking / trending of OOS’s or equivalent for each site submitting products.
Lead all on-site external regulatory and account audits collaboratively with VP, Quality. Implement & conduct internal audit program for all lab operations and policies.
Develop and Implement LIMS system for the lab to work with the production facilities QMS systems, as applicable.
- All other duties may be assigned as required
Knowledge, Skills, and Abilities
- Capable of excellent leadership and interpersonal communication skills including presentation skills
- Capable of routinely providing metrics data and executive summaries for all projects and daily operations
- Capable of managing and coordinating several tasks / projects at a time
- Capable of working in a fast-paced environment while balancing business priorities
- Self-motivated and highly organized without daily on-site direct supervision; capable of working flexible hours to support manufacturing & quality operations of all submitting sites
- Ability to follow and enforce all company and regulatory requirements including GLP, cGMP as applicable
- Strong enforcement & coaching skills. Ability to communicate technical information to non-technical personnel
- Ability to develop methods / metrics to measure worker proficiency & efficiency
Bachelor’s degree in Life Sciences
Minimum 3 years of Management experience
Advanced knowledge and application of FDA regulations (cGMP, GLP, Data Integrity)
Minimum of 2 years’ experience operating / managing a testing or contract laboratory
Knowledge of Good Laboratory Practices (GLP) / Current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP)
Knowledge of Quality Assurance / Quality Control and validation programs or systems
Bachelor’s degree in Microbiology or Chemistry
Green Belt / Black Belt certification
Physical Demands and Work Environment:
The requirements listed below are representative of the knowledge, skill and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Majority of time can be spent wearing protective laboratory attire (Examples of attire include: goggles, gloves, lab coat, shoe covers, hair net, and face cover)
- Minimal exposure to physical risks, such as operating dangerous equipment or working with chemicals
- Must be able to stand for long periods of time
- Must be able to sit in front of computer for long periods of time
- Must be able to wear required safety equipment for long periods of time
- Fine motor skills must be sufficient to manipulate pipettes and small syringes
- Corrected vision close to 20/20 and acceptable for driving
Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.(sm)
Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.
Job Keywords: Laboratory, Houston, Texas, Management, Microbiologist, Chemist, GMP, GLP, Science