Indiana Stem Jobs

Mobile Indiana Career Connect Logo

Job Information

Catalent Pharma Solutions Senior Statistician – Integrated BIO Network in Bloomington, Indiana

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

A Senior Statistician is needed to support Catalent Pharma Solutions for development and manufacturing of pharmaceutical clients' products and processes. Responsibilities include leading cross functional efforts at Catalent Pharma Solutions by driving and sustaining statistical thinking and appropriate use of statistical methodologies across development and drug substance and drug product manufacturing. Specific areas of involvement include (but not limited to) statistically designed experiments, sampling strategy, stability studies, packaging, collaboration and review of regulatory specifications, evaluation of control/capability in manufacturing, process/analytical method validation/transfers and developing and providing statistical training. Strong collaborator is needed who can work effectively cross-functionally and across sites.

The Statistician does not need to relocate. Some travel to relevant sites will be needed to evaluate capabilities and implement projects.

Catalent Pharma Solutions in Bloomington, Indiana is a state of the art, GMP manufacturing facility, providing one million sq/ft of a drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.

The Role

  • Provide statistical expertise, study design, and analysis and communicate data driven decisions for biologics process improvements, process understanding, method development, transfer and validation, and stability studies in collaboration with personnel.

  • Applies a complete understanding of theories and principles for one's technical discipline

  • Maintain statistical skills by learning new methodologies, suggesting which methods to use in analysis, and justifying methods selected

  • Communicate study results and statistical concepts in meetings, oral presentations, internal reports, and presentations at professional association meetings

  • Works independently on a broad range of difficult problems

  • Suggests new, innovative solutions to statistical problems

  • Demonstrate a thorough understanding of process/systems to the manufacture of drug product

  • Proficiency in the use of statistical software (eg: JMP, MiniTab)

  • Skilled at-risk mitigation for function

  • Excellent problem-solving skills and written/verbal communication skills

  • Strong interpersonal skills and ability to work effectively on teams

The Candidate

  • PhD in sciences, engineering, statistics or related technical field plus greater than 2 years experience OR

  • Master’s degree plus greater than 5 experience OR

  • Bachelor’s degree or higher preferred in Statistics or related scientific field plus greater than 8 years of experience

  • Experience in biologics drug substance development and manufacturing

  • Experience in fill finish and packaging of biologics

  • Experience in understanding analytical method development and robustness

  • Experience biologics regulatory filings (IND, BLA, etc) and knowledge of statistical tools to support specifications

Catalent Benefits:

  • Defined career path and annual performance review and feedback process

  • Diverse, inclusive culture

  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

  • Competitive salary with quarterly bonus potential

  • Community engagement and green initiatives

  • Generous 401K match and Paid Time Off accrual

  • Medical, dental and vision benefits effective day one of employment

  • Tuition Reimbursement

  • On-site fitness center and wellness programs

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

DirectEmployers