Job details
Salary $103,530 - $197,270 a year job type full-time
Benefits pulled from the full job description
401(k) 401(k) matching company car dental insurance health insurance paid time off show 1 more benefit
Full job description
The position
Objectives and scope of position
Behind every presentation of each product sold by roche is the involvement of pharma global technical operations (pt)Starting with phase i of the development process and continuing through to product maturity, pt makes medicines at sites around the world and includes more than 10 000 employees worldwide.
`global technical development` (ptd) is an organization of over two thousand people globally that are integral for the mission of roche to develop meaningful medicines for patientsTherefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needsThe mandate of the group is, to expertly deliver the pipeline and supply quality products to patientsThe group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
“u.sBiologics technical development” (ptdu) develops and supports manufacturing processes, formulations, delivery devices, analytical methods, packaging solutions and materials to meet end-to-end (discovery to commercialization) development needs of the gred protein pharmaceutical pipeline through innovation, efficiency, and collaboration to enable the delivery of novel medicines that can meet the critical needs of patients.
In the device and packaging development department (ptdu-d), we are responsible for the development of medical devices, combination products and packaging systems for r&d portfolio drug productsOur activities comprise a wide range of engineering disciplines ranging from the initial definition of product requirements to first commercialization and subsequent product care considering required regulatory, legislative, ecological, economical and technical aspects.
As a srPackaging engineer, you support the establishment of a world-class packaging organization by providing technical expertise in the development, qualification and deployment of new packaging systems, with a heavy work plate focus on leading parenteral pharmaceutical primary container and closure system topics(e.gStrategy definition for primary packaging, evaluation and development of new primary packagingComponents, definition / transfer of test methods, platform lifecycle management.) you will work on a variety of packaging initiatives and lead the development and qualification of global packaging solutions of assigned projects for clinical and commercial useYou will play a vital role in designing the best packaging for new molecules coming through the pipeline and launchesThis activity involves close cooperation and cross-functional interaction with technical development teams, regulatory, operations, cmo’s, quality, suppliers and other involved stakeholders.
*opportunity to work remotely with future travel to our south san fransisco headquarters*
Job responsibilities
General responsibilities:
Lead packaging engineering projects within global teams in order to meet predefined timelines, quality, and budget.
Deliver innovative, best in class packaging solutions to meet patient and business needs.
Develop and qualify global packaging solutions for products through the packaging lifecycle, understanding customer needs and leveraging the organization.
Innovate: evaluate and screen new technologies, and new materials and/or packaging solutions based on patient, product, regulatory, business or technical requirements.
Ensure compliance with international procedures and external regulations.
Actively support a culture of knowledge sharing and interaction across packaging and device development teams.
Parenteral primary packaging responsibilities:
Serve as parenteral pharmaceutical primary container and closure system expert for the packaging community, including training and technical mentorship to team members in the department.
Design and execute activities in support of components and container closure systems for non-combination drug product (e.gGlass vials, elastomeric stoppers, cartridges, and bags), including selection, characterization testing, and system qualification for dosage form-specific projects in alignment with quality system procedures and business practicesProvide technical review for components and container closure systems specifications and incoming release testing protocols.
Contribute to safety assessments of material of construction of components and container closure systems.
Provide technical expertise to the network for trouble-shooting parenteral primary packaging related issues including component defects, drug product manufacturing process and inspection.
Qualifications
Education & qualifications:
This position requires a bachelor degree in materials science, packaging engineering or related field; with a minimum of 8+ yrs w/ bachelors working in packaging development lifecycle activities in the pharma, medical device, food or cosmetic industry.
For this position, you bring the following qualifications:
Strong knowledge and experience in parenteral primary container and closure systems required.
Knowledge in extractables and leachables including associated industry standards and regulations.
Technical expertise in packaging design, test methods and packaging equipment and process qualification / validation.
Sound knowledge of legislation, regulatory guidance and industry standards for packaging (e.gIsta/astm, design and validation / qualification, iso, usp/eu/jp compendia, ich, and 21 cfr part4).
Excellent documentation practices: user requirements, design control, specifications, qualification protocols/reports for packaging systems, risk assessments, and shipping qualification activities.
Innovative spirit leading to industry best practicesDesign thinking, design management, drives creativity.
Project management skills and experience in cross-functional projects.
Excellent presentation and interpersonal communication skills.
Fosters team effectiveness, team spirit, team alignment, shares risks within the team beyond the function.
English language proficiency required.
Traveling is required approx10-20%
For colorado-based applicants, the expected salary range for this position is $103,530 - 197,270Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by lawThis position is eligible to earn incentive compensation that is calculated and paid in accordance with the applicable incentive compensation plan for the roleThis position also qualifies for the benefits listed below.
Benefits
Roche offers highly competitive benefit plans and programs, including: •medical, dental and vision insurance
401(k) and 401(k) matching
Paid time off
Company car (field employees)
#li-sk2
#ptddevice#
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around usGenentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
Genentech requires all new hires to be fully vaccinated against covid-19 as of their start dateThis requirement is a condition of employment at genentech, and it applies regardless of whether the position is located at a genentech campus or is fully remoteIf you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
Job facts
Job sub category
Manufacturing
Schedule
Full time
Job type
Regular
Posted date
Apr 28th 2022
Job id
202201-104785
Hiring insights
Job activity
Posted 30+ days ago
