You oversee compliance and improvement of manufacturing processes while managing external quality standards. Your role includes assessing acquisitions, developing agreements, and collaborating with teams to ensure effective commercialization support.
Anforderungen
- •Desired drug substance and product experience
- •Effective communication in multicultural settings
- •Ability to influence people
- •Ability to build collaborative relationships
- •Familiarity with Elanco Global Quality Standards
- •Experience in corporate TS/MS business processes
- •Bachelor in a Scientific Field preferred
- •Minimum 15 years pharma/biopharma experience
- •Experience in various manufacturing technologies
- •On-site experience in manufacturing site lead-team
Deine Aufgaben
- •Ensure products and processes are compliant and improving.
- •Oversee external manufacturing to meet quality standards.
- •Implement and manage manufacturability review processes.
- •Maintain robust manufacturing processes throughout product lifecycle.
- •Assess technical capabilities of potential business acquisitions.
- •Assist in developing Quality and Commercial Agreements.
- •Review and approve technical transfer plans for acquisitions.
- •Collaborate with TSMS team to develop talent pipeline.
- •Coordinate with R&D for Pilot Plant support allocation.
Deine Vorteile
Value-based culture
Dynamic flat hierarchy
Personal development
Organizational development
Influence on design and strategy
Flexible working arrangements
Original Beschreibung
# Senior Director - Technical Services (m/w/d)
**DE - Monheim** | **Full time**
**Position Description:**
The Senior Director TS / MS Elanco Manufacturing Network is responsible for providing technical and strategic leadership for Elanco’s TS/MS function within the network. This role is accountable for all technical product and process support activities for the following Elanco Manufacturing Sites (Kiel, Banwol, Huningue, Santa Clara, Kansas City) and oversight of Solids/Parenteral central support as warranted to internal Elanco sites/EEM hubs. Additionally, in support of our IPP Mission, this role has responsibilities for maintaining a TS/MS network SME/Product steward group for solid/parental technology platforms and oversight of the Huningue Pilot plant. The TS/MS network SME/Product Stewardship group may partner with Elanco EEM Hubs, TS/MS internal sites, and R&D to support Elanco’s IPP Agenda. The technical transfer, Value Capture, and Network rationalization agenda may include consolidation of CMO and internal product manufacturing footprints, new product introductions from R&D, BD&L acquisitions, or moving existing commercial products between CMOs and to/from internal Elanco sites and vice versa.
**Functions, Duties, Tasks:**
* Elanco Manufacturing-TSMS: Responsibilities include: a) ensuring that products and manufacturing processes are in control, capable, compliant, and continuously improving, b) ensuring that the TS/MS external manufacturing organization meets the Global Quality and Global Contract Manufacturing Standards. The network TSMS Sr. Director is responsible for ensuring that the right TS functional capability is in place at each of the designated internal sites.
* Elanco’s commercialization process as it relates to new products introduced to manufacturing units: Responsibilities include: a) ensuring the robust implementation and hand-over per the manufacturability review process and b) ensuring that the right technical capability (TS/MS) is in place for Elanco commercial hand-over activities within the manufacturing units. c) ensuring that robust manufacturing processes are installed and maintained throughout the product lifecycle.
* Potential Business Development and Acquisitions: Responsibilities include: a) assessing technical capabilities/gaps of potential business deals or acquisitions, b) assisting in the development of Quality/Technical and Commercial Agreements, c) reviewing and approving technical transfer plans or other technical elements to do with acquisitions.
* Partner with the wider TSMS team to grow the talent pipeline within the function
* Partner with R&D to assure appropriate allocation of support for commercialization activities as it pertains to the Pilot Plant Mission in Huningue.
**Minimum Qualification (education, experience and/or training, required certifications):**
* Given the anticipated agenda both drug substance and drug product experience is desired.
* Effective communication in multi-cultural settings
* Ability to influence people
* Ability to build collaborative relationships with areas inside and outside of Elanco
* Familiarity with the Elanco Global Quality Standards
* Experience in corporate TS/MS business processes
* Bachelor in a Scientific Field. Advanced Degree (Master, PhD) or equivalent experience preferred.
* Minimum of 15 years of relevant pharma/biopharma experience, including Contract Manufacturing Support/Management
* Experience in a variety of manufacturing technologies and platforms, e.g. large molecule API, small molecule API, liquids, parenteral, oral solid dose, etc.
* On-site experience as a member of the manufacturing site lead team
**Additional Preferences:**
* Domestic and/or international travel required
* No medical sensitivities to Elanco Animal Health products
* Shift: Monday-Friday, normal flexible hours
**Other Information:**
* Direct reports: 3-10, 5-6 matrixed/dotted line reports
* Travel: Directors visit each of their network’s manufacturing sites and need to be available for travel to support significant investigations.
**What we offer:**
* Strong value-based culture
* Dynamic environment in a flat hierarchy
* Personal and organizational development
* Possibility to influence the design and strategic direction of the organization
* Flexible working / partially home office
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status