Director of Technical Support, Development, & Pre-Commercial Services

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Director of Technical Support, Development, & Pre-Commercial Services acts as a key technical interface between Simtra's customers and both our commercial and development service teams. This role supports Account Management and Business Development in promoting Simtra's development service capabilities, helping to secure new projects. The Director Technical Support will collaborate closely with the Technical Support team, the development service teams and business operations to craft tailored service proposals that not only meet but exceed client expectations and requirements.

What you’ll do:

• Consult customers on Simtra's capabilities related to
• Drug product formulation development
• Compatibility studies drug formulation – container closure system
• Analytical method development and transfer
• Lyophilisation cycle development and optimization
• Process development, optimization, qualification and validation
• Clinical batch production
• Scale -up GMP batches
• Antibody-drug conjugates (ADC) C&P and F/F processes
• Serve as the technical interface between the customer and Simtra's Commercial and Development Services team:
• Be an active part of the account team and support the development and execution of specific account plans.
• Build and maintain strong relationships with customers and mapping their decision-making processes.
• Explore customer pipeline strategies and industry trends, sharing insights with relevant stakeholders.
• Proactively support the development and execution of commercial strategies for Development Services.
• Implement Simtra's Development Service strategy to ensure strong, day-to-day customer relationships.
• Interface with customers and account managers to gather background information and technical requirements for customer projects.
• Act as liaison between Account Manager/ Business Development Executives and Development Service teams to translate customer requirements into appropriate proposals and support the acquisition of new development projects.
• Prepare technical presentations to position Simtra's services based on customer needs and evolving industry trends.
• Represent Simtra at tradeshows, conferences, technical seminars, and webinars.
• Maintain ongoing customer support throughout the project lifecycle, ensuring customer needs are continually met, addressing technical inquiries, and fostering long-term relationships for customer retention.
• Provide technical troubleshooting and problem-solving expertise to address challenges encountered by customers during development and ensure successful project outcomes.
• Conduct training sessions and workshops for customers and internal teams to ensure understanding and optimal use of Simtra's technical solutions and capabilities.
• Lead and mentor the Technical Support team, providing guidance, training, and development opportunities to build high-performing teams capable of delivering exceptional results and driving customer satisfaction.
• Represent Simtra as a thought leader in the industry, participating in high-profile conferences, trade shows, and webinars to enhance the company’s visibility and reputation.

Basic Qualifications: 

• Bachelor’s degree in Pharmacy, Biochemistry, Chemistry, Biology, or a related technical field; Advanced degree in Pharmacy, Biochemistry, Chemistry, Biology, or related technical field preferred; equivalent leadership experience in the pharmaceutical industry will also be considered.
• 8-10 years of experience in the pharmaceutical industry or service provider environment, with significant leadership in antibody-drug conjugates (ADC) development, manufacturing, or pharmaceutical drug development.
• 8-10 years of experience in technical support, technical business development, or drug product development, with a proven track record of leading cross-functional teams, driving strategic initiatives, and delivering client-focused solutions.

Preferred Knowledge, Skills and Abilities:

• Leadership & Team Management: Proven experience managing and mentoring high-performing teams in a global, virtual environment.
• Strategic Vision: Ability to develop and execute long-term strategic plans that align with company goals and drive business growth.
• Stakeholder Management: Experience in engaging with C-suite executives, regulatory authorities, and key industry stakeholders to influence decision-making.
• Demonstrated ability to think strategically and align solutions with client needs and business objectives.
• Ability to work autonomously in a fast-paced and complex environment, demonstrating adaptability and a self-motivated work ethic.
• Proven ability to manage multiple priorities with a sense of urgency and drive successful outcomes.
• Ability to quickly comprehend and effectively communicate complex, technical information, translating it into clear business solutions for clients.
• Exceptional interpersonal skills, with a proven ability to build rapport, influence stakeholders, and manage key relationships across organizational levels, business units, and clients.
• Proven ability to proactively anticipate and identify client needs, making tailored recommendations that drive value.
• Ability to thrive in a virtual, global environment, collaborating effectively across different time zones and cultures.
• Excellent English language skills (written/oral), additional languages preferred.

Travel Requirements:

• Must be able to travel up to 25% of the time, including internationally

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
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