Procter & Gamble

Makes household and personal care products

Manager – Material Process Delivery

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours

Full-timeJakarta, IndonesiaNo salary listed

About the Job

Requirements

Sound knowledge and 10–14 years of experience with various dosage forms, including expertise handling and troubleshooting commercial-scale manufacturing equipment and processes for fluid bed processor granulation (top spray and bottom spray), film coating, sugar-coating tablets, hard gelatin capsules, oral liquids, nasal dosage forms, and small-volume parenteral injections.
Strong oral and written English and Bahasa Indonesia skills, including communication, interpersonal, and presentation skills.
Good digital skills for generating technical documents in a digitized environment.
Good project management, planning, and organizing skills.
Knowledge of ICH guidelines on stability, process validation, quality, and risk management, and pharmacopoeias including IP, BP, USP, and EP.
Sound knowledge of technical documentation before and after technology transfer, aligned with Asian, ICH, and WHO technical and quality guidelines.
Expertise composing and reviewing the quality module of CTD dossiers, Parts P and S.
A master's degree in pharmaceutical sciences or a Ph.D. in pharmaceutical science.
10–14 years of experience.

Responsibilities

Coordinate with MPD Process, Analytical, and Packaging functions and multifunctional teams, including ESS QA, GTM QA, contract manufacturing site production and QA, CQA, ESS Operations, and Purchases, to support product technology transfers at existing and new contract manufacturing locations across the AMA region and coordinate with other regions when transfers are planned from sending units such as EU and LATAM.
Review and approve technical documents, including TTP, MFR, HTS, and TTR, before and after technology transfer, and review dossiers of prospective C&G products to be outsourced.
Lead supplier qualification activities for new suppliers in accordance with P&G standard operating procedures.
Participate in periodic multifunctional team meetings and present technical matters to update leadership and team members on regional project progress from the MPD Process perspective.
Own document management software (Veeva) workflows for initiating change control, deviation, and CAPA systems, and create, review, and approve technical standards for raw materials, intermediates, and finished goods.
Ensure compliance with P&G PHC standard operating procedures affecting MPD Process; participate in internal quality audits, ensure compliance, and draft responses to audit observations.
Create and review technical write-ups submitted to BOH in response to deficiency letters.
Initiate and maintain stability data for technology-transfer evaluation batches, non-commercial and commercial process validation batches, savings initiatives, and business continuity plan batches, including commercial process validation and small-scale EO batches.
Support the MPD Compliance Function in ensuring compliance with relevant internal and external regulations.
Review and interpret stability results, including out-of-specification and out-of-trend results, in accordance with ICH and WHO guidelines.
Coordinate support for technology transfer of new and existing products to contract manufacturing locations and support multifunctional teams during manufacturing of initial EO batches and validation batches.
Coordinate with MPD Process team members and multifunctional teams on technical tasks throughout the product life cycle.
Monitor, review, and approve technical documents and stability study data for commercial and non-commercial process validation batches maintained under various conditions in accordance with Asian, ICH, and WHO stability guidelines.
Manage product life-cycle activities involving manufacturing technology, new raw material qualification, and troubleshooting.
Participate in technical troubleshooting and NSS activities at manufacturing locations as needed.
Comply with digital specifications management and quality systems, including Veeva for change control, deviation management, and CAPA.
Liaise with LRA and LCM colleagues on regulatory requirements, review and approve technical documentation and dossier data for different markets, and prepare technical sections of CTD and non-CTD dossiers in accordance with Part P and Part S requirements.
Participate in supplier qualification for in-scope raw materials and follow the applicable procedures; liaise with the Safety Team to obtain safety clearance for individual raw materials.

Desired Qualifications

A master's degree in business administration from a recognized institute is an add-on qualification.

Job Location

JAKARTA GENERAL OFFICE

Job Description

P&G was founded over 180 years ago as a simple soap and candle company. Today, we're the world’s largest consumer goods company and home to iconic, trusted brands that make life a little bit easier in small but significant ways. We've spanned three centuries thanks to three simple ideas: leadership, innovation and citizenship. The insight, innovation and passion of hardworking teams has helped us grow into a global company that is governed responsibly and ethically, that is open and clear, and that supports good causes and protects the environment. This is a place where you can be proud to work and do something that matters.

Dedication from Us:

You'll be at the core of breakthrough innovations, be given exciting assignments, lead initiatives, and take ownership and responsibility, in creative workspaces where new insights thrive. All the while, you'll receive outstanding training to help you become a leader in your field.

What we Offer:

Continuous mentorship – you will collaborate with peers and receive both formal training as well as day-to-day mentoring from your manager multifaceted and encouraging work environment– employees are at the centre, we value every individual and support initiatives, promoting agility and work/life balance.

Overview of the Job:

A new BAND 1 position at Material Process Delivery (MPD) Base Business (BB) department (sub function of Product Supply) for market Asia, Middle, East Africa (AMA) region. Position is based out of Jakarta, Indonesia & however it’s a location free role & so need travel to different location across region for TT activity, which will be need based.

The candidate will be responsible for multifaceted tech skills of pharmaceutical product formulation development & technology transfers, right from stages of formulation development to scale up & commercial scale process validation at various contract manufacturing sites across Asian region. Going forward, life cycle management regards to manufacturing technology, new raw material qualification & trouble shooting shall be handled.

The role includes tech transfer of new/existing products to contract manufacturing (CM) locations and to collaborate/support to multi-function teams (ESS- Production, QA, Procurement, CM site MFTs) during manufacturing of initial EO batches, validation batches.

The role requires co-ordination with MPD- Process team members & MFTs on various technical tasks during product life cycle management. Monitor, review, approve technical documents & the stability study data of commercial/Non-commercial PV batches kept at various conditions in line with Asian, ICH/WHO stability guidelines.

Your Team

The New BAND 1 role shall be based out at Jakarta Indonesia & will report to Sr. Manager MPD -Process (B2) BB AMA PHC based out at Mumbai. There are 3 sub-functional wings of MPD viz. Process Development &, Pkg. Material development.

MPD AMA PHC BB team had total 12 No. of FTEs stationed at India Mumbai.

How success looks like

Tech transfer of existing products manufactured at Existing contract manufacturing (CM) locations in Indonesia to New contract manufacturing locations & those are exported to different markets within Asean Countries. Role needs travelling to CM locations across region (66-75% travel time needed for this role)
Participation in NSS & Technical trouble shooting activities at manufacturing locations (need based).
Compliance to various P&G system like Digital specs. Management & Quality system, e.g. Veeva for CCP, Deviation management, CAPA.
Liaison with LRA /LCM folks for various RA requirements as per BOH requirement. Review & approvals of technical documents & data of Dossier for different markets as per Part P & Part S technical part of CTD /Non CTD dossier.
Participate in review of stability study of various batches incubated in line with Asian, ICH/WHO stability guidelines & related task thereof.
Participate in supplier qualification of in scope raw materials being used in the formulation & to follow respective SOP for material qualification. To liaison with Safety Team regards to safety clearance of individual raw materials.

Responsibilities of the role

Coordination with MPD (process, Analytical, Pkg Function) and various Multi-functional Teams (ESS QA, GTM QA, CM site production & QA, CQA, ESS Operations, Purchases) so to facilitate support in Technology Transfer (TT) of products at existing & new CM [contract manufacturing] locations across AMA region as well as to co-ordinate with other region while product TT is planned from sending units of other region e.g. EU, LATAM.
Review & approve various technical documents like TTP/MFR/HTS/TTR prior & post TT and dossiers of prospective C&G products to be outsourced.
Shall lead the supplier qualification activities per P&G SOP for qualification of New Supplier.
Participate in periodic meetings with multi-functional Teams and opine/present on technical matters so to update leadership & MFT members on the progress of regional projects’ from MPD Process PoV.
Ownership of document management software (VEEVA) for initiating change control, deviation & CAPA systems including create/review/approve technical standards for RM, Intermediates and FG.
Ensure compliance to P&G PHC SOPs those impacts MPD Process function. Participate in internal quality audits , its compliance & draft the response to audit observations.
Creation/review of technical writeup that is to be furnished to BOH in response to Deficiency letter issued.
Participation in stated below activities, Documentation, review of stability studies i.e. Initiation & maintenance of stability data of following types of batches.
To support MPD – Compliance Function in ensuring internal & external regulations in this regards.
Shall be responsible for review & interpretation of stability results [have sound knowledge of ICH & WHO guidelines on OOS/OOT, Stability studies]
- Existing site to New Site Tech. Transferred products Evaluation batches, Non- commercial PV batches & commercial PV batches.
- Savings initiatives (NSS) & Business Continuity Plan Initiatives– batches e.g. commercial PV batches/Small scale (EO) batches.

Role Requirements

Sound knowledge (10-14 years) of various dosage forms having expertise in handling /trouble shooting in various equipment used in commercial scale manufacturing of these dosage forms e.g. FBP granulation (Top spray, bottom spray) & Film coating, Sugar-coating tablet techniques, along with hard Gelatine capsules, Oral Liquid, Nasal & Injection [SVP]dosage form is a needed skill.
Excellent communication, interpersonal skills, power point presentation skills, both oral and written English & Bahasa (Indonesia).
Agile, shall have good managerial skills, shall be a team leader and should have problem solving ability.
Should have a positive attitude, result oriented, competent and a good team-player with a customer Centric approach.
Good digital/soft skills to work in the digitized space required for technical documents' generation.
Good Project Management, Planning & Organizing skills.
Knowledge of various ICH guidelines on stability, process validation and quality & risk Management, Pharmacopoeia like IP/BP/USP, EP etc.
Sound knowledge of technical documentation [ pre & post Technology Transfer documentation] is required & which shall be aligned with Global Technical/quality guidelines viz, Asian, ICH, WHO. Expert in compose/review of CTD dossier quality module – Part P& Part S.

Job Qualifications

Master degree in Pharmaceutical sciences /Ph. D. in pharmaceutical science from a reputed College
Master’s degree in business administration from recognized institute, would be an add-on qualification for the role.
10-14 years of experience

About Us

We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax® and more. Our community includes operations in approximately 70 countries worldwide.

Visit http://www.pg.com to know more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.

Job Schedule

Full time

Job Number

R000160620

Job Segmentation

Experienced Professionals

About the Company

Procter & Gamble

Makes household and personal care products

Procter & Gamble makes household and personal care products that consumers use for cleaning, grooming, hygiene, and everyday health. Its portfolio includes Tide laundry detergent, Pampers diapers, Gillette razors, and Crest toothpaste, with brands tailored to different needs and markets. The company develops and manufactures these branded goods, then earns revenue by selling them through retailers, distributors, online stores, and direct consumer channels. Its businesses span beauty and hair care, shaving, oral and personal health, fabric and home care, and baby and family care. Founded in 1837, Procter & Gamble is headquartered in Cincinnati, Ohio.

Company size: 10,001+
Company stage: IPO
Headquarters: Cincinnati, OH
Founded: 1837

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